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TESTS GRANTED WAIVED STATUS UNDER CLIA

CPT CODE(S) TEST NAME MANUFACTURER USE


81002 Dipstick or tablet reagent urinalysis – Various Screening of urine to monitor/diagnose various diseases/conditions, such as
non-automated for bilirubin, glucose, diabetes, the state of the kidney or urinary tract, and urinary tract infections
hemoglobin, ketone, leukocytes, nitrite,
pH, protein, specific gravity, and
urobilinogen

81025 Urine pregnancy tests by visual color Various Diagnosis of pregnancy


comparison

82270 Fecal occult blood Various Detection of blood in feces from whatever cause, benign or malignant
82272 (colorectal cancer screening)
G0394 (Contact
your Medicare
carrier for claims
instructions.)

82962 Blood glucose by glucose monitoring Various Monitoring of blood glucose levels
devices cleared by the FDA for home
use

83026 Hemoglobin by copper sulfate – non- Various Monitors hemoglobin level in blood
automated

84830 Ovulation tests by visual color Various Detection of ovulation (optimal for conception)
comparison for human luteinizing
hormone

85013 Blood count; spun microhematocrit Various Screen for anemia

85651 Erythrocyte sedimentation rate – non- Various Nonspecific screening test for inflammatory activity, increased for majority
automated of infections, and most cases of carcinoma and leukemia

This list includes updates from Change Request 5715


TESTS GRANTED WAIVED STATUS UNDER CLIA

CPT CODE(S) TEST NAME MANUFACTURER USE


80101QW (This test 1. Phamatech At Home Drug Test Phamatech Screening test for the presence/detection of amphetamine in urine
may not be covered (Model 9063)
in all instances.
Contact your
Medicare carrier for
claims instructions.)
2. Phamatech QuickScreen One Step Phamatech
Amphetamine Test
80101QW (This test 1. Accu-Stat Drugs of Abuse Home Accu-Stat Diagnostics, Inc. Screening test for the presence/detection of cannabinoids (THC) in urine
may not be covered Test for Marijuana (THC)
in all instances.
Contact your
Medicare carrier for
claims instructions.)
2. ADC CLIA Waived Marijuana Advantage Diagnostics
(THC) Test Corporation (ADC)
3. First Check Diagnostics LLC, First Acon Laboratories, Inc.
Check Home Drug Test Marijuana
4. Phamatech At Home Drug Test Phamatech
(Model 9078)
5. Phamatech At Home Drug Test Phamatech
(Model 9078T)
6. Worldwide Medical Corporation, Worldwide Medical
First Check® Home Drug Test Corporation
(THC)
80101QW (This test 1. Phamatech At Home Drug Test Phamatech Screening test for the presence/detection of cocaine metabolites in urine
may not be covered (Model 9073)
in all instances.
Contact your
Medicare carrier for
claims instructions.)
2. Phamatech At Home Drug Test Phamatech
(Model 9073T)

This list includes updates from Change Request 5715 2


* Newly added waived test system
TESTS GRANTED WAIVED STATUS UNDER CLIA

CPT CODE(S) TEST NAME MANUFACTURER USE


80101QW (This test 3. Phamatech QuickScreen One Step Phamatech Screening test for the presence/detection of cocaine metabolites in urine
may not be covered Cocaine Screening Test
in all instances.
Contact your
Medicare carrier for
claims instructions.)
(cont.)
80101QW (This test 1. Phamatech At Home Drug Test Phamatech Screening test for the presence/detection of methamphetamines in urine
may not be covered (Model 9068)
in all instances.
Contact your
Medicare carrier for
claims instructions.)
2. Phamatech QuickScreen One Step Phamatech
Methamphetamine Test
80101QW (This test DynaGen NicCheck I Test Strips Dynagen, Inc. Detects nicotine and/or its metabolites in urine, which is used as an aid in
may not be covered indicating the smoking status of an individual and as an aid in the
in all instances. identification of a smoker as a low or high nicotine consumer
Contact your
Medicare carrier for
claims instructions.)
80101QW (This test 1. Phamatech At Home Drug Test Phamatech Screening test for the presence/detection of opiates in urine
may not be covered (Model 9083)
in all instances.
Contact your
Medicare carrier for
claims instructions.)
2. Phamatech QuickScreen One Step
Phamatech
Opiate Screening Test
80101QW (This test 1. Phamatech At Home Drug Test Phamatech Screening test for the presence/detection of phencyclidine in urine
may not be covered (Model 9133)
in all instances.
Contact your
Medicare carrier for
claims instructions.)

This list includes updates from Change Request 5715 3


* Newly added waived test system
TESTS GRANTED WAIVED STATUS UNDER CLIA

CPT CODE(S) TEST NAME MANUFACTURER USE


80101QW (This test 2. Phamatech QuickScreen One Step Phamatech Screening test for the presence/detection of phencyclidine in urine
may not be covered PCP Screening Test
in all instances.
Contact your
Medicare carrier for
claims instructions.)
(cont.)
80101QW (This test 1. Accu-Stat Drugs of Abuse Home Accu-Stat Diagnostics, Inc. Screening test for the presence/detection of cannabinoids (THC) and cocaine
may not be covered Test for Marijuana (THC) and metabolites in urine
in all instances. Cocaine (COC)
Contact your
Medicare carrier for
claims instructions.)
2. Advantage Diagnostics Advantage ADC
Marijuana (THC) and Cocaine
Home Drug Test
3. ADC CLIA Waived Marijuana ADC
(THC) and Cocaine Test
4. Forefront Diagnostics Forefront Diagnostics, Inc.
Drugfree@Home THC/COC Test
Kit
5. Worldwide Medical Corporation, Worldwide Medical
First Check® Home Drug Test Corporation
(THC-COC)
80101QW (This test 1. ADC CLIA Waived Multiple Drug ADC Screening test for the presence/detection of cannabinoids (THC), cocaine
may not be covered Test Card metabolites, methamphetamines, opiates, and phencyclidine (PCP) in urine
in all instances.
Contact your
Medicare carrier for
claims instructions.)
2. Advantage Diagnostics Corporation Advantage Diagnostics
ADC Multiple Drug Test Card Corporation
3. Alatex Scientific Peace of Mind Advantage Diagnostics
Multiple Drugs of Abuse Test Corporation

This list includes updates from Change Request 5715 4


* Newly added waived test system
TESTS GRANTED WAIVED STATUS UNDER CLIA

CPT CODE(S) TEST NAME MANUFACTURER USE


80101QW (This test Phamatech At Home Drug Test (Model Phamatech Screening test for the presence/detection of amphetamines, cannabinoids
may not be covered 9150T) (THC), cocaine metabolites, methamphetamines, and opiates in urine
in all instances.
Contact your
Medicare carrier for
claims instructions.)
80101QW (This test Worldwide Medical Corporation, First Worldwide Medical Screening test for the presence/detection of cannabinoids (THC), cocaine
may not be covered Check® Home Drug Test Panel 4 Corporation metabolites, opiates and methamphetamines in urine
in all instances. (THC-COC-OPI-MET)
Contact your
Medicare carrier for
claims instructions.)
80101QW (This test 1. Accu-Stat Drugs of Abuse Home Accu-Stat Diagnostics, Inc. Screening test for the presence/detection of amphetamines, cannabinoids
may not be covered Test for Marijuana, Cocaine, (THC), cocaine metabolites, methamphetamines, opiates, and phencyclidine
in all instances. Amphetamine, Methamphetamines, in urine
Contact your Opiates and Phencyclidine
Medicare carrier for
claims instructions.)
2. accutest Multi-Drug, Multi-Line Acon Laboratories, Inc.
Screen Test Device
3. Acon One Step Multi-Drug, Multi- Acon Laboratories, Inc.
Line Screen Test Device
(Professional Use)
4. Biotechnostix Rapid Response One Acon Laboratories, Inc.
Step Multi-Drug, Multi-Line Screen
Test Device
5. iCassette Multi-Drug, Multi-Line Acon Laboratories, Inc.
Screen Test Device

6. RediScreen Multi-Drug, Multi-Line Acon Laboratories, Inc.


Screen Test Device
7. Redwood Toxicology Laboratory Innovacon
Reditest 6 Cassette substance abuse
screening device {Professional
Use}
This list includes updates from Change Request 5715 5
* Newly added waived test system
TESTS GRANTED WAIVED STATUS UNDER CLIA

CPT CODE(S) TEST NAME MANUFACTURER USE


80101QW (This test 1. Biotechnostix Rapid Response Acon Laboratories, Inc Screening test for the presence/detection of amphetamines, cannabinoids
may not be covered Multi-Drug, Multi-Line Screen Test (THC), cocaine metabolites, methamphetamines,
in all instances. Card with Integrated Cup methylenedioxymethamphetamine, opiates, and phencyclidine in urine
Contact your
Medicare carrier for
claims instructions.)
2. Drug Detection Devices Ltd. Multi- Innovacon
Drug Multi-Line Screeners Dip
Drug Test With the Integrated
Screeners AutoSplit KO Test Cup
3. First Check Diagnostics First Check First Check Diagnostics LLC
Multi Drug Cup
4. Innovacon Integrated E-Z Split Key Innovacon
Cup II {Professional Use}
5. Wolfe Drug Testing RealityCheck Innovacon
Integrated Specimen Cup
80101QW (This test Branan Medical Corporation ToxCup Branan Medical Corporation Screening test for the presence/detection of amphetamines, barbiturates,
may not be covered Drug Screen Cup benzodiazepines, cannabinoids (THC), cocaine metabolites, methadone,
in all instances. methamphetamines, methylenedioxymethamphetamine, opiates, oxycodone,
Contact your and phencyclidine in urine
Medicare carrier for
claims instructions.)
80101QW (This test 1. Innovacon Multi-Clin Drug Screen Innovacon, Inc. Screening test for the presence/detection of amphetamines, barbiturates,
may not be covered Test Device* benzodiazepines, cannabinoids (THC), cocaine metabolites,
in all instances. methylenedioxymethamphetamine, opiates, oxycodone, phencyclidine,
Contact your propoxyphene and tricyclic antidepressants in urine
Medicare carrier for
claims instructions.)
2. Jant Pharmacal Accutest MultiDrug Innovacon, Inc.
ER11 Drug Screen Test Device*

This list includes updates from Change Request 5715 6


* Newly added waived test system
TESTS GRANTED WAIVED STATUS UNDER CLIA

CPT CODE(S) TEST NAME MANUFACTURER USE


80101QW (This test 1. Branan Medical Corporation Branan Medical Corporation Screening test for the presence/detection of amphetamines, barbiturates,
may not be covered Fastect II Drug Screen Dipstick benzodiazepines, cannabinoids (THC), cocaine metabolites, methadone,
in all instances. Test methamphetamines, methylenedioxymethamphetamine, opiates, oxycodone,
Contact your phencyclidine and tricyclic antidepressants in urine
Medicare carrier for
claims instructions.)
2. Branan Medical Corporation, Branan Medical Corporation
FasTox Multiple Drug Dipcard
3. Branan Medical Corporation, Branan Medical Corporation
QuickTox Drug Screen Dipcard
4. First Check Diagnostics First Check First Check Diagnostics LLC
12 Drug Test
80178QW ReliaLAB Inc. InstaRead Lithium Akers Laboratories, Inc. Measures lithium blood levels in whole blood
System {fingerstick or venipuncture
whole blood}
81002, 1. Bayer Multistick Pro 7G Reagent Bayer Diagnostics Screening of urine to monitor/diagnose various diseases/conditions, such as
82570QW Strips diabetes, the state of the kidney or urinary tract, and urinary tract infections
and semi-quantitative measurement of creatinine in urine for the detection of
patients at risk for developing kidney damage
2. Bayer Multistick Pro 10LS Reagent Bayer Diagnostics Screening of urine to monitor/diagnose various diseases/conditions, such as
Strips diabetes, the state of the kidney or urinary tract, and urinary tract infections
and semi-quantitative measurement of creatinine in urine for the detection of
patients at risk for developing kidney damage
3. Bayer Multistick Pro 11 Reagent Bayer Diagnostics
Strips
81003QW 1. Bayer Clinitek 50 Urine Chemistry Bayer Screening of urine to monitor/diagnose various diseases/conditions, such as
Analyzer – qualitative dipstick for diabetes, the state of the kidney or urinary tract, and urinary tract infections
glucose, bilirubin, ketone, specific
gravity, blood, pH, protein,
urobilinogen, nitrite, leukocytes –
automated
2. Biosys Laboratories Optima Urine Biosys Laboratories
Anlayzer

This list includes updates from Change Request 5715 7


* Newly added waived test system
TESTS GRANTED WAIVED STATUS UNDER CLIA

CPT CODE(S) TEST NAME MANUFACTURER USE


81003QW (cont.) 3. Chemstrip Mini UA – qualitative Boehringer Mannheim Screening of urine to monitor/diagnose various diseases/conditions, such as
dipstick for glucose, bilirubin, Corporation diabetes, the state of the kidney or urinary tract, and urinary tract infections
ketone, specific gravity, blood, pH,
protein, urobilinogen, nitrite,
leukocytes – automated
4. Hypoguard Diascreen® Urine Hypoguard USA, Inc.
Chemistry Analyzer
5. Physician Sales & Service, Inc. PSS Biosys Laboratories, Inc.
Select Urine Analyzer
6. Roche Diagnostics Urisys 1100 Roche Diagnostics Corp.
Urine Analyzer
7. Roche Diagnostics/Boehringer Roche
Mannheim Chemstrip 101 Urine Diagnostics/Boehringer
Analyzer MannheimCorporation
8. Teco Diagnostics URITEK TC-101 Teco Diagnostics
Urine Strip Reader
9. ThermoBiostar™ PocketChem™ ThermoBiostar™
UA
81003QW, Bayer Clinitek Status Urine Chemistry Bayer Healthcare, Llc Screening of urine to monitor/diagnose various diseases/conditions, such as
82570QW Analyzer diabetes, the state of the kidney or urinary tract, and urinary tract infections
and semi-quantitative measurement of creatinine in urine for the detection of
patients at risk for developing kidney damage
81007QW Diatech Diagnostics Uriscreen (for OTC Savyon/USA Detects catalase in urine which is associated with urinary tract infections
use) (UTIs). White blood cells and some bacteria associated with UTIs are
positive for catalase.
82010QW PTS Bioscanner (for OTC use) - for Polymer Technology Measures ketones in whole blood
blood ketones Systems, Inc.
1. Abbott Laboratories, Medisense
82010QW, Abbott Laboratories, Inc. Monitoring of blood glucose levels and measures ketones in whole blood
Products Precision™ Xtra™
82962 Advanced Diabetes Management
System (K983504)

This list includes updates from Change Request 5715 8


* Newly added waived test system
TESTS GRANTED WAIVED STATUS UNDER CLIA

CPT CODE(S) TEST NAME MANUFACTURER USE


82010QW, 2. Abbott Medisense Precision Xtra Abbott Laboratories, Inc
Monitoring of blood glucose levels and measures ketones in whole blood
82962 (cont.) Advanced Diabetes Management
System (K040814)
82042QW, Abaxis Piccolo Point of Care Chemistry Abaxis, Inc. Measures alanine aminotransferase, albumin, alkaline phosphatase, amylase,
82150QW, Analyzer (Liver Panel Plus Reagent aspartate aminotransferase, gamma glutamyltransferase, total bilirubin and
82247QW, Disc){whole blood} total protein levels in whole blood
82977QW,
84075QW,
84157QW,
84450QW,
84460QW
82042QW, Arkay SPOTCHEM EZ Chemistry Polymedco, Inc. Measures albumin, total calcium, creatinine, glucose and total protein
82310QW, Analyer (Spotchem II Basicpanel 1) levels in whole blood
82565QW, { Whole Blood}*
82947QW,
82950QW,
82951QW,
82952QW,
84520QW
82044QW, 1. Bayer Clinitek 50 Urine Chemistry Bayer Corp. Semi-quantitative measurement of microablumin and creatinine in urine for
82570QW Analyzer - for microalbumin, the detection of patients at risk for developing kidney damage
creatinine
82044QW, 2. Bayer Diagnostics/ Bayer Inc. Semi-quantitative measurement of microablumin and creatinine in urine for
82570QW (cont.) MICROALBUSTIX™ the detection of patients at risk for developing kidney damage
Reagent Strip
82247QW, Arkay SPOTCHEM EZ Chemistry Polymedco, Inc. Measures alanine aminotransferase, alkaline phosphatase, aspartate
84075QW, Analyer (Spotchem II Basicpanel 2) aminotransferase, total bilirubin and total protein levels in whole blood
84157QW, { Whole Blood}*
84450QW,
84460QW

This list includes updates from Change Request 5715 9


* Newly added waived test system
TESTS GRANTED WAIVED STATUS UNDER CLIA

CPT CODE(S) TEST NAME MANUFACTURER USE


82055QW (This test 1. OraSure Technologies Q.E.D. A- OraSure Technologies, Inc. Quantitative determination of alcohol (ethanol) in saliva
may not be covered 150 Saliva Alcohol Test
in all instances.
Contact your
Medicare carrier for
claims instructions.)
2. OraSure Technologies Q.E.D. A- OraSure Technologies, Inc.
350 Saliva Alcohol Test
3. STC Diagnostics Q.E.D. A150 STC Technologies Inc.
Saliva Alcohol Test
4. STC Diagnostics Q.E.D. A350 STC Technologies Inc.
Saliva Alcohol Test
82120QW, 1. Litmus Concepts FemExam Litmus Concepts, Inc. Qualitative test of a vaginal fluid sample for elevated pH (pH greater than or
83986QW TestCard (from vaginal swab) equal to 4.7) and the presence of volatile amines
2. Quidel QuickVue Advance pH and Quidel Corporation
Amines Test
82271QW 1. Aerscher Hemaprompt FG Aerscher Diagnostics Rapid screening test to detect the presence of gastric occult blood
2. SmithKline Gastroccult SmithKline
82271QW, Beckman Coulter Primary Care Beckman Coulter, Inc. Rapid screening test to detect the presence of gastric occult blood and
83986QW Diagnostics Gastrocult® determine the pH (acid-base balance) of gastric aspirates
82274QW 1. Beckman Coulter Hemoccult ICT Beckman Coulter, Inc. Detection of blood in feces from whatever cause, benign or malignant
G0328QW (colorectal cancer screening) by immunoassay
2. Clarity Hemosure One-Step Wampole Laboratories
Immunological Fecal Occult Blood
Test
3. Clearview Ultra FOB Test RAC Medical Group, Inc.
4. Enterix InSure™ Fecal Occult Enterix, Inc.
Blood Test
5. Enterix InSure Fecal Enterix, Inc.
Immunochemical Test
6. Enterix Insure II Fecal Enterix, Inc.
Immunochemical Test
This list includes updates from Change Request 5715 10
* Newly added waived test system
TESTS GRANTED WAIVED STATUS UNDER CLIA

CPT CODE(S) TEST NAME MANUFACTURER USE


82274QW 7. immoCare Fecal Occult Blood Test Care Diagnostic, Inc. Detection of blood in feces from whatever cause, benign or malignant
G0328QW (cont.) (colorectal cancer screening) by immunoassay
8. Immunostics, Inc., hema-screen Immunostics, In
Specific Immunochemical Fecal
Occult Blood Test
9. InSure Quik Fecal Enterix, Inc.
Immunochemical Test (F.I.T.)
10. OcculTech Fecal Occult Blood YD Diagnositcs Corp.
Rapid Test
11. Teco Rapid Fecal Occult Blood Teco Diagnostics
(FOB) Card Test
82465QW (Contact 1. Advanced Care Johnson & Johnson Cholesterol monitoring
your Medicare
carrier for claims
instructions.)
2. Boehringer Mannheim Accu-Chek Boehringer Mannheim
InstantPlus Cholesterol
3. ChemTrak AccuMeter ChemTrak
4. ENA.C.T Total Cholesterol Test ActiMed Laboratories, Inc.
5. ActiMed Laboratories ENA.C.T. ActiMed Laboratories, Inc.
Total Cholesterol Test (PDU)
6. Lifestream Technologies Lifestream Technologies,
Cholesterol Monitor Inc.
7. Lifestream Technologies Personal Lifestream Technologies,
Cholesterol Monitor Inc.
8. Polymer Technology Systems Polymer Technology
(PTS) MTM Bioscanner 1000 (for Systems, Inc.
OTC use) for cholesterol
9. PTS Bioscanner Test Strips Polymer Technology
Chloesterol Systems, Inc.

This list includes updates from Change Request 5715 11


* Newly added waived test system
TESTS GRANTED WAIVED STATUS UNDER CLIA

CPT CODE(S) TEST NAME MANUFACTURER USE


82465QW (Contact 1. Piccolo Point of Care Chemistry Abaxis, Incorporated Measures total cholesterol, HDL cholesterol, and triglycerides in whole
your Medicare Analyzer (Lipid Panel Reagent blood
carrier for claims Disc) (Whole Blood)
instructions.),
83718QW,
84478QW,
80061QW
2. Polymer Technology Systems Polymer Technology
CardioChek PA Analyzer {PTS Systems, Inc.
Panels Lipid Panel Test Strips}
82465QW (Contact Cholestech LDX (Lipid Profile – ALT Cholestech Corp. Measures alanine aminotransferase, total cholesterol, HDL cholesterol, and
your Medicare (GPT)){Whole Blood}* triglycerides in whole blood
carrier for claims
instructions.),
83718QW,
84460QW,
84478QW,
80061QW

82465QW (Contact 1. Polymer Technology Systems Polymer Technology Measures total cholesterol and monitors blood glucose levels
your Medicare Cardiochek PA Analyzer (PTS Systems, Inc.
carrier for claims Panels Chol + Glu Test Panel)
instructions.),
82962
2. Roche Diagnostics AccuChek
Instant Plus Dual Testing System
82465QW(Contact Polymer Technology Systems Polymer Technology Measures total cholesterol and HDL cholesterol in whole blood
your Medicare Cardiochek PA Analyzer (PTS Panels Systems, Inc.
carrier for claims CHOL+HDL Test Panel Test Strips)
instructions.),
83718QW

This list includes updates from Change Request 5715 12


* Newly added waived test system
TESTS GRANTED WAIVED STATUS UNDER CLIA

CPT CODE(S) TEST NAME MANUFACTURER USE


83718QW, Polymer Technology Systems Polymer Technology Measures HDL cholesterol, triglycerides, and glucose levels in whole blood
84478QW, CardioChek PA Analyzer (PTS Panels Systems, Inc.
82947QW, Metabolic Chemistry Panel Test Strips)
82950QW,
82951QW,
82952QW

82465QW (Contact Cholestech LDX Cholestech Measures total cholesterol, HDL cholesterol, triglycerides, and glucose
your Medicare levels in whole blood
carrier for claims
instructions.),
83718QW,
84478QW,
82947QW,
82950QW,
82951QW,
82952QW,
80061QW
82523QW Ostex International Osteomark NTX Ostex International Inc. Measures normalized cross-linked N-telopeptides of type 1 collagen in urine
Point of Care Prescription Home Use
82679QW (This test Clearplan Easy Fertility Monitor (for Unipath Limited Detection of luteinizing hormone and estrone 3 glucuronide in urine to
may not be covered luteinizing hormone and estrone 3 identify the optimal time for conception
in all instances. glucuronide)
Contact your
Medicare carrier for
claims
instructions.),
83002QW
82947QW, 1. HemoCue B-Glucose Photometer HemoCue Measures glucose levels in whole blood
82950QW,
82951QW,
82952QW
2. HemoCue® Glucose 201 HemoCue, Inc.
Microcuvettes and Glucose 201
Analyzer

This list includes updates from Change Request 5715 13


* Newly added waived test system
TESTS GRANTED WAIVED STATUS UNDER CLIA

CPT CODE(S) TEST NAME MANUFACTURER USE


82985QW LXN Fructosamine Test System LXN Corporation Used to evaluate diabetic control, reflecting diabetic control over a 2-3 week
period (Not a useful test for screening diabetes mellitus)
82962, 1. LXN Duet Glucose Control LXN Corporation Monitoring of blood glucose levels and measures fructosamine, which is
82985QW Monitoring System used to evaluate diabetic control, reflecting diabetic control over a 2-3 week
period
2. LXN IN CHARGE Diabetes LXN Corporation
Control System
83001QW 1. Acon Laboratories, Inc. FSH Acon Laboratories, Inc. Detects follicle stimulating hormone in urine
Menopause Predictor Test
2. Acon Laboratories, Inc. FSH One Acon Laboratories, Inc
Step Menopause Test Device
{Professional Use}
3. Acon Laboratories, Inc. FSH One Acon Laboratories, Inc
Step Menopause Test Strip
{Professional Use}
4. Applied Biotech, Inc. RU25 Plus Applied Biotech, Inc.
FSH Menopause Test
5. Biotechnostix, Inc. Rapid Response Acon Laboratories, Inc
FSH One Step Menopause Test
Device
6. Genosis Fertell Female Fertility Genosis, Inc.
Test*
7. Genua Menopause Monitor Test Genua 1944 Inc
8. Synova Healthcare MenocheckPro Applied Biotech, Inc.
(Professional Use)

83036QW 1. Axis-Shield Afinion AS100 Axis-Sheild Poc As Measures the percent concentration of hemoglobin A1c in blood, which is
Analyzer used in monitoring the long-term care of people with diabetes
2. Bayer DCA 2000 – glycosylated Bayer Corp.
hemoglobin (Hgb A1c)
3. Bayer DCA 2000+ - glycosylated Bayer Corp.
hemoglobin (Hgb A1c)

This list includes updates from Change Request 5715 14


* Newly added waived test system
TESTS GRANTED WAIVED STATUS UNDER CLIA

CPT CODE(S) TEST NAME MANUFACTURER USE


83036QW (cont.) 4. Metrika A1c Now™ - Professional Metrika, Inc. Measures the percent concentration of hemoglobin A1c in blood, which is
Use (K000887) used in monitoring the long-term care of people with diabetes
5. Metrika A1c Now for Professional Metrika, Inc.
Use (K020235)
6. Metrika DRx® HbA1c Metrika, Inc.
(Professional Use Test System)
83037QW 1. Bio-Rad Micromat II Hemoglobin Bio-Rad Laboratories Measures the percent concentration of hemoglobin A1c in blood, which is
A1c Prescription Home Use Test used in monitoring the long-term care of people with diabetes using devices
cleared by the FDA for home use
2. Cholestech GDX A1C Test Cholestech Corporation
(Prescription Home Use)
3. Metrika A1c Now for Prescription Metrika, Inc.
Home Use (K020234)
4. Provalis Diagnostics Glycosal™ Provalis Diagnostics Ltd.
HbA1c Test
5. Provalis Diagnostics In2it In-Office Provalis Diagnostics Ltd
Analyzer (II) A1C Prescription
Home Use Test System
83518QW 1. Beckman Coulter ICON Microalb Beckman Coulter Determination of low concentrations of albumin in urine by immunoassay,
which is helpful for early detection in patients at risk for developing renal
disease
2. Boehringer Mannheim Chemstrip Boehringer Mannheim
Micral
3. Diagnostic Chemicals Diagnostic Chemicals
ImmunoDip™ Urinary Albumin Limited
Test
4. Diagnostic Chemicals Diagnostic Chemicals
ImmunoDip™ Urinary Albumin Limited (USA)
Screen (Urine Dipstick)
5. Roche Diagnostics Chemstrip Roche Diagnostics
Micral (urine dipstick) Corporation
83605QW KDK Corporation Lactate Pro System KDK Corporation Quantitative measurement of lactate in whole blood

This list includes updates from Change Request 5715 15


* Newly added waived test system
TESTS GRANTED WAIVED STATUS UNDER CLIA

CPT CODE(S) TEST NAME MANUFACTURER USE


83655QW ESA Biosciences LeadCare II Blood ESA Biosciences, Inc. Quantitative measurement of blood lead in whole blood
Lead Testing System (whole blood)

83718QW PTS Bioscanner (for OTC use) - for Polymer Technology Measures HDL cholesterol in whole blood
HDL cholesterol Systems, Inc.
83721QW Polymer Technology Systems Polymer Technology Measures LDL cholesterol in whole blood
Cardiochek PA Analyzer Systems, Inc.
83880QW 1. Biosite Triage Meter {Whole Biosite Incorporated Quantitative measurement of b-type natuiretic peptide (BNP)
Blood}
2. Biosite Triage Meter Plus {Whole
Blood}
83986QW All qualitative color comparison pH Various pH detection (acid-base balance) in body fluids such as semen, amniotic
testing - body fluids (other than blood) fluid, and gastric aspirates
83986QW FemTek pHEM-ALERT® FemTek, LLC Vaginal pH detection (acid-base balance)
84443QW 1. ThyroTec, Inc. ThyroTest Whole ThyroTes, Inc. Qualitative determination of human thyroid stimulating hormone (TSH) in
Blood TSH Test whole blood, which is a rapid TSH assay for hypothyroidism screening in
adults
2. Jant Pharmacal Accutest TSH Screening Devices Canada
{Whole Blood}* Inc.
84520QW, Arkray SPOTCHEM EZ Chemistry Arkray, Inc. Quantitative determination of blood urea nitrogen (BUN) and aspartate
84450QW Analyzer{whole blood} aminotransferase in whole blood
84450QW Cholestech LDX Aspartate Cholestech Corporation Quantitative determination of aspartate aminotransferase in whole blood
Aminotransferase (AST)(SGOT)
84460QW Cholestech LDX® Alanine Cholestech Corporation Quantitative determination of alanine aminotransferase in whole blood
Aminotransferase (ALT) Test

PTS, Inc. Bioscanner 2000 for Polymer Technology Measures triglycerides in whole blood
84478QW Triglycerides Systems, Inc.
84703QW Bayer Clinitek 50 Urine Chemistry Bayer Corp Diagnosis of pregnancy
Analyzer - for HCG, urine
85014QW Wampole STAT-CRIT Hct Wampole Laboratories Screen for anemia

85018QW 1. Biosafe Laboratories, Inc., Biosafe Laboratories, Inc. Measures hemoglobin level in whole blood
Anemiapro Self Screener
This list includes updates from Change Request 5715 16
* Newly added waived test system
TESTS GRANTED WAIVED STATUS UNDER CLIA

CPT CODE(S) TEST NAME MANUFACTURER USE


85018QW (cont.) 2. HemoCue Donor Hemoglobin HemoCue Measures hemoglobin level in whole blood
Checker System HemoCue
3. HemoCue Hemoglobin System HemoCue
4. HemoCue Hemoglobin 201+ HemoCue
(Capillary, Venous, Arterial Whole
Blood)
5. HemoCue Hemoglobin HemoCue
201+/HemoCue Hemoglobin
Microcuvette System
6. HemoCue Hb 301 System HemoCue
7. GDS Diagnostics HemoSite Meter - GDS Technology, Inc.
for hemoglobin
8. GDS Technology STAT-Site MHgb GDS Technology
Test System
85576QW Accumetrics VerifyNow Aspirin Assay Accumetrics Inc. Qualitative assay to measure platelet aggregation
85610QW (Contact 1. AvoSure PT System (prescription Avocet Medical, Inc. Aid in screening for congenital deficiencies of Factors II, V, VII, X; screen
your Medicare home use) for deficiency of prothrombin; evaluate heparin effect, coumadin or warfarin
carrier for claims effect; screen for Vitamin K deficiency
instructions.)
2. AvoSure Pro (professional use) Avocet Medical, Inc.
3. CoaguChek PST for Prothrombin Boehringer Mannheim
Time Corporation
4. HemoSense INRatio System HemoSense, Inc.
5. ITC Protime Microcoagulation International Technidyne
System for Prothrombin Time Corporation (ITC)
6. International Technidyne ProTime International Technidyne
Microcoagulation System (ProTime Corporation
3 Cuvette) Prescription Home Use
7. International Technidyne ProTime International Technidyne
Microcoagulation System (ProTime Corporation
3 Cuvette) Professional Use

This list includes updates from Change Request 5715 17


* Newly added waived test system
TESTS GRANTED WAIVED STATUS UNDER CLIA

CPT CODE(S) TEST NAME MANUFACTURER USE


85610QW (cont.) 8. Lifescan Harmony™ INR Lifescan, Inc. Aid in screening for congenital deficiencies of Factors II, V, VII, X; screen
(Contact your Monitoring System -- Prescription for deficiency of prothrombin; evaluate heparin effect, coumadin or warfarin
Medicare carrier for Home Use and Professional Use effect; screen for Vitamin K deficiency
claims instructions.)
9. Roche/Boehringer Mannheim Roche Diagnostics/
CoaguChek System for Professional Boehringer Mannheim
Use Corporation
10. Roche Diagnostics Coaguchek PST Roche Diagnostics
11. Roche Diagnostics Coagu Chek S Roche Diagnostics
Systems Test (for prothrombin
time)
12. Roche Diagnostics CoaguChek XS Roche Diagnostics
86294QW 1. Bion Diagnostic Sciences BTA stat Bion Diagnostic Sciences, Immunoassay for the qualitative detection of bladder tumor associated
Test (for home use) Inc. antigen in urine of persons diagnosed with bladder cancer, and used as an
aid in the management of bladder cancer patients
2. Matritech, Inc. NMP22® Maritech, Inc.
BladderCheck™ Test for
Professional and Prescription Home
Use

86308QW 1. Acon Mononucleosis Rapid Test Acon Laboratories, Inc. Qualitative screening test for the presence of heterophile antibodies in
Device {Whole Blood} human whole blood, which is used as an aid in the diagnosis of infectious
mononucleosis
2. Acon Mononucleosis Rapid Test Acon Laboratories, Inc.
Strip {Whole Blood}
3. Applied Biotech SureStep Mono Applied Biotech, Inc.
Test (whole blood)
4. BioStar Acceava Mono Test (whole Wyntek Diagnostics, Inc.
blood)
5. Cardinal Health SP Brand Rapid Cardinal Health
Test Mono {Whole Blood}*

This list includes updates from Change Request 5715 18


* Newly added waived test system
TESTS GRANTED WAIVED STATUS UNDER CLIA

CPT CODE(S) TEST NAME MANUFACTURER USE


86308QW (cont.) 6. Clearview MONO Whole Blood* Inverness Medical Qualitative screening test for the presence of heterophile antibodies in
Professional Diagnostics human whole blood, which is used as an aid in the diagnosis of infectious
mononucleosis
7. Clearview Mono-plus II Applied Biotech, Inc.
8. Genzyme Contrast Mono (whole Genzyme Diagnostics
blood)
9. Genzyme OSOM Mono Test Wyntek Diagnostics, Inc.
10. Icon Mono Beckman Coulter, Inc.
11. Immuno Detector Mono {Whole Princeton Biomeditech Corp.
Blood}*
12. Instant Technologies iScreen Acon Laboratories, Inc.
Mononucleosis Rapid Test Device
{Whole Blood}
13. Instant Technologies iScreen Acon Laboratories, Inc.
Mononucleosis Rapid Test Strip
{Whole Blood}
14. Jant Accutest Infectious Applied Biotech, Inc.
Mononucleosis Test (whole blood)
15. LifeSign Status Mono {for whole Princeton BioMeditech
blood} Corp.
16. LifeSign UniStep Mono Test Princeton BioMeditech
(whole blood) Corp.
17. McKesson Medi-lab Performance Applied Biotech, Inc.
Infectious Mononucleosis Test
18. Meridian ImmunoCard STAT Applied Biotech, Inc.
Mono (for whole blood)
19. PerMaxim RediScreen Acon Laboratories, Inc.
Mononucleosis {Whole Blood}
20. Polymedco, Inc. Poly stat Mono Applied Biotech, Inc.
21. Quidel Cards O.S. Mono (for whole Quidel Corporation
blood)

This list includes updates from Change Request 5715 19


* Newly added waived test system
TESTS GRANTED WAIVED STATUS UNDER CLIA

CPT CODE(S) TEST NAME MANUFACTURER USE


86308QW (cont.) 22. Quidel QuickVue+ Infectious Quidel Corporation Qualitative screening test for the presence of heterophile antibodies in
Mononucleosis (Whole Blood) human whole blood, which is used as an aid in the diagnosis of infectious
mononucleosis
23. RAC Medical Clarity MONO Acon Laboratories, Inc.
Mononucleosis Rapid Test Device
{Whole Blood}
24. Remel RIM® A.R.C. Mono Test Applied Biotech, Inc.
25. Seradyn Color Q Mono (whole Genzyme Diagnostics
blood)
26. Signify Mono Whole Blood* Inverness Medical
Professional Diagnostics
27. Wampole Mono-Plus WB Wampole Laboratories
28. Wyntek Diagnostics OSOM Mono Wyntek Diagnostics, Inc.
Test (whole blood)
29. Wyntek Signify Mono Test Wyntek Diagnostics, Inc.
86318QW 1. Abbott FlexPak HP Test for whole SmithKline Diagnostics, Inc. Immunoassay for rapid, qualitative detection of IgG antibodies specific to
blood Helicobacter pylori in whole blood
2. Abbott TestPack Plus H. pylori (for Abbott Laboratories
whole blood)
3. Acon® H. pylori Test Device ACON Laboratories, Inc.
4. Applied Biotech SureStep H. pylori Applied Biotech, Inc.
WB Test (whole blood)
5. Beckman Coulter Primary Care Beckman Coulter, Inc.
Diagnostics Flexsure HP Test for
IgG Antibodies to H. Pylori in
Whole Blood
6. Becton Dickinson Link 2 H. pylori Cortecs Diagnostics Limited
Rapid Test (for whole blood)
7. Cardinal Health SP Brand Rapid Applied Biotech Inc.
Test H. pylori (K990892)

This list includes updates from Change Request 5715 20


* Newly added waived test system
TESTS GRANTED WAIVED STATUS UNDER CLIA

CPT CODE(S) TEST NAME MANUFACTURER USE


86318QW (cont.) 8. Cardinal Health SP Brand Rapid Innovacon Immunoassay for rapid, qualitative detection of IgG antibodies specific to
Test H. pylori {Whole Helicobacter pylori in whole blood
Blood}(K024350/A15)*
9. Fisher Healthcare Sure-Vue H. Innovacon
pylori Test {Whole Blood}*
10. Germaine Laboratories, Aimstep H. Acon Laboratories, Inc.
pylori {whole blood}
11. Immunostics Detector H. Pylori Princeton Biomeditech Corp.
WB (H. pyloi Antibody Test)
{Whole Blood}*
12. Instant Technologies iScreen Acon Laboratories, Inc.
H.pylori Rapid Test Device
13. Inverness Medical Clearview H. Innovacon
pylori Test {whole blood}
14. JANT Pharmacal Corp. H. pylori Applied Biotech, Inc.
WBTest
15. LifeSign Status H.pylori (for whole Princeton BioMeditech
blood)
16. Meridian BioScience ImmunoCard Applied Biotech, Inc.
STAT! H.pylori Whole Blood Test

17. Polymedco, Inc. Poly stat H.pylori Applied Biotech, Inc.


18. QuickVue One-Step H. Pylori Test Quidel
for Whole Blood
19. Quidel QuickVue One-Step Quidel Corporation
H.pylori II Test.
20. Remel RIM® A.R.C. H.pylori Test Remel
21. SmithKline Diagnostics FlexSure SmithKline Diagnostics, Inc.
HP Test for IgG Antibodies to H.
pylori in Whole Blood
22. Trinity Uni-Gold™ H.pylori Trinity BioTech

This list includes updates from Change Request 5715 21


* Newly added waived test system
TESTS GRANTED WAIVED STATUS UNDER CLIA

CPT CODE(S) TEST NAME MANUFACTURER USE


86318QW (cont.) 23. Wampole Laboratories Clearview Applied Biotech , Inc. Immunoassay for rapid, qualitative detection of IgG antibodies specific to
H. pylori II {finger stick or whole Helicobacter pylori in whole blood
blood}
86618QW Wampole PreVue™ B. burgdorferi Wampole Laboratories Qualitative detection of IgG/IgM antibodies to Borrelia burgdorferi
Antibody Detection Assay (causative agent of Lyme disease) in whole blood

86701QW 1. OraSure Technologies OraQuick OraSure Technologies, Inc. Qualitative immunoassay to detect antibodies to Human Immunodeficiency
Rapid HIV-1 Antibody Test Virus Type 1 (HIV-1)
2. OraSure OraQuick Rapid HIV-1 OraSure Technologies, Inc.
Antibody Test – fingerstick and
venipuncture whole blood
3. Trinity Biotech Uni-Gold Trinity Biotech Qualitative immunoassay to detect antibodies to Human Immunodeficiency
Recombigen HIV Test (Fingerstick, Virus Type 1 (HIV-1)
Venipuncture Whole Blood)
86703QW OraSure OraQuick Advance Rapid HIV- OraSure Technologies, Inc. Qualitative immunoassay to detect antibodies to Human Immunodeficiency
1/2 Antibody Test {oral fluid, Virus Type 1 (HIV-1) and Type 2 (HIV-2) in oral fluid, fingerstick whole
fingerstick whole blood and blood and venipuncture whole blood specimens
venipuncture whole blood}
87077QW 1. Ballard Medical Products CLOtest Ballard Medical Products Presumptive identification of Helicobacter pylori in gastric biopsy tissue,
which has been shown to cause chronic active gastritis (ulcers)
2. Delta West CLOtest Delta West
Tri-Med Specialties
3. GI Supply HP-FAST Mycoscience Labs, Inc.
4. GI Supply, Div. Chek-Med Systems GI Supply
HP One
5. Medical Instruments Corporation Medical Instruments
Pronto Dry H. pylori Corporation
6. Serim Pyloritek Test Kit Serim
87210QW 1. Stesans Maybe?Mom Mini LEC Associates Detects ferning pattern in saliva which is used in the determination of
Ovulation Microscope ovulation (optimal for conception)
2. O2 Unlimited Donna Ovulation O2 Unlimited Corp.
Tester

This list includes updates from Change Request 5715 22


* Newly added waived test system
TESTS GRANTED WAIVED STATUS UNDER CLIA

CPT CODE(S) TEST NAME MANUFACTURER USE


87449QW ZymeTx Zstatflu® Test Zymetx, Inc. Qualitative determination of influenza types A and B from throat swab
specimens that does not differentiate between types A and B
87804QW Quidel QuickVue® Influenza Test Quidel Corporation Qualitative detection of influenza type A and type B antigens from nasal
swab, nasal wash or nasal aspirate specimens that does not differentiate
between influenza types A and B
87804QW 1. Quidel Quickvue Influenza A+B Quidel Corporation Qualitative detection of influenza type A and type B antigens from nasal
Test swab, nasal wash or nasal aspirate specimens that does differentiate between
influenza types A and B
2. BinaxNOW® Influenza A & B Test Binax, Inc.
in nasopharyngeal (NP) swab and
nasal wash/aspirate specimens,
K041049
3. BinaxNOW Influenza A & B Test Binax, Inc.
{Nasopharyngeal (Np) Swab and
Nasal Wash/Aspirate Specimens},
K053126
87804QW 1. Binax Now® Flu A Test Binax, Inc. Qualitative detection of influenza type A antigen in nasopharyngeal
specimens
2. SA Scientific SAS Influenza A Test SA Scientific, Inc.

87804QW 1. Binax Now® Flu B Test Binax, Inc. Qualitative detection of influenza type B antigen in nasopharyngeal
specimens
2. SA Scientific SAS Influenza B Test SA Scientific, Inc.
87807QW 1. Binax NOW RSV Test (K021687) Binax, Inc. Rapid immunoassay for the qualitative detection of respiratory syncytial
virus antigen
2. Binax NOW RSV Test Binax, Inc.
(K032166/A005)
3. Fisher Scientific Sure-Vue RSV SA Scientific, Inc.
Test

This list includes updates from Change Request 5715 23


* Newly added waived test system
TESTS GRANTED WAIVED STATUS UNDER CLIA

CPT CODE(S) TEST NAME MANUFACTURER USE


87807QW (cont.) 4. Integrated Biotechnology Quick Integrated Biotechnology Rapid immunoassay for the qualitative detection of respiratory syncytial
Lab RSV Test Corp. virus antigen
5. SA Scientific SAS RSV Alert SA Scientific, Inc.
87808QW Genzyme OSOM Trichomonas Rapid Genzyme Corp. Immunoassay for the qualitative detection of Trichomonas vaginalis
Test antigens from vaginal swabs
87880QW 1. Abbott Signify Strep A Test (from Wyntek Diagnostics, Inc. Rapidly detects GAS antigen from throat swabs and used as an aid in the
throat swab only) diagnosis of GAS infection, which typically causes strep throat, tonsillitis,
and scarlet fever
2. Acon® Strep A Rapid Strip Test Acon Laboratories, Inc.
3. Acon® Strep A Twist Rapid Test Acon Laboratories, Inc.
4. Applied Biotech SureStep Strep A Applied Biotech, Inc.
(II) (direct from throat swab)
5. Beckman Coulter ICON DS Strep Princeton BioMeditech
A Test Corp.
6. Beckman Coulter ICON SC Strep A Acon Laboratories, Inc
Test
7. Beckman Coulter Primary Care Acon Laboratories, Inc.
Diagnostics ICON DS Strep A
8. Beckman Coulter Primary Care Beckman Coulter
Diagnostics ICON FX Strep A
Immunochemical Strep A Test
9. Becton Dickinson LINK 2 Strep A Applied Biotech, Inc.
Rapid Test (direct from throat
swab)
10. Binax NOW Strep A Test Binax
11. BioStar Acceava Strep A Test Wyntek Diagnostics, Inc.
(direct specimen only)
12. Biotechnostix Rapid Response Acon Laboratories Co.
Strep A Rapid Test Device
13. Biotechnostix Rapid Response Acon Laboratories Co.
Strep A Rapid Test Strip

This list includes updates from Change Request 5715 24


* Newly added waived test system
TESTS GRANTED WAIVED STATUS UNDER CLIA

CPT CODE(S) TEST NAME MANUFACTURER USE


87880QW (cont.) 14. Cardinal Health SP Brand Rapid Applied Biotech Inc. Rapidly detects GAS antigen from throat swabs and used as an aid in the
Test Strep A Dipstick(K033855) diagnosis of GAS infection, which typically causes strep throat, tonsillitis,
and scarlet fever
15. Cardinal Health SP Brand Rapid Innovacon
Test Strep A Dipstick
(K010582/A028)*
16. DE Healthcare Products, TruView DE Healthcare Products
Strep A Test
17. DE Healthcare Products TruView Acon Laboratories, Inc.
Strep A Cassette Test
18. Fisher HealthCare Sure-Vue Strep Applied Biotech, Inc.
A (direct from throat swab)
19. Genzyme Contrast Strep A (direct Genzyme Diagnostics
from throat swab)
20. Genzyme OSOM® Strep A Ultra Genzyme Corporation
Test – 25 Test Kit Size
21. Genzyme OSOM Ultra Strep A Genzyme General
Test
22. Germaine Laboratories StrepAim Germaine Laboratories, Inc.
Rapid Dipstick Test
23. Germaine Laboratories Strep AIM Germaine Laboratories, Inc.
Tower
24. Henry Schein Inc, One Step+ Strep Henry Schein
A Test
25. Immunostics Detector Strep A Acon Laboratories, Inc
Direct
26. Immunostics Immuno/Strep A Acon Laboratories, Inc
Detector
27. Instant Technologies iStrep Strep A Acon Laboratories, Inc
28. Inverness Medical BioStar Acceava Innovacon
Strep A Test

This list includes updates from Change Request 5715 25


* Newly added waived test system
TESTS GRANTED WAIVED STATUS UNDER CLIA

CPT CODE(S) TEST NAME MANUFACTURER USE


87880QW (cont.) 29. Jant Pharmacal AccuStrip Strep A Applied Biotech, Inc. Rapidly detects GAS antigen from throat swabs and used as an aid in the
(II) (direct from throat swab) diagnosis of GAS infection, which typically causes strep throat, tonsillitis,
and scarlet fever
30. Laboratory Supply Company (LSC) Acon Laboratories Co.
PEP Strep A Cassette Test
31. LSC PEP Strep A Dipstick Test Acon Laboratories Co.
32. LifeSign LLC Status Strep A Princeton BioMeditech
33. Mainline Confirms Strep A Dots Applied Biotech, Inc.
Test (direct from throat swab)
34. McKesson Medi-Lab Performance Applied Biotech, Inc.
Strep A Test Dipstick
35. Meridian Diagnostics ImmunoCard Applied Biotech, Inc.
STAT Strep A (direct from throat
swab)
36. Polymedco, Inc. Poly stat A (II) Applied Biotech, Inc.
37. Polymedco Poly Stat Strep A Applied Biotech, Inc
Liquid Test
38. QuickVue In-Line One-Step Strep Quidel Corporation
A Test (K934484)
39. QuickVue® Dipstick Strep A Quidel Corporation

40. Quidel QuickVue® In-Line Strep A Quidel Corporation


41. RAC Medical Clarity Strep A Acon Laboratories Co.
Rapid Test Strips
42. Remel RIM® A.R.C. Strep A Test Applied Biotech, Inc.
43. SmithKline ICON Fx Strep A Test Binax
(from throat swab only)
44. Stanbio Laboratory E-Z Well Strep Acon Laboratories Co.
A Rapid Device Test
45. Stanbio QuStick Strep A Stanbio Laboratory
46. Wyntek Diagnostics OSOM Strep Wyntek Diagnostics, Inc
A Test
This list includes updates from Change Request 5715 26
* Newly added waived test system
TESTS GRANTED WAIVED STATUS UNDER CLIA

CPT CODE(S) TEST NAME MANUFACTURER USE


87880QW (cont.) 47. Wyntek OSOM® Ultra Strep A Wyntek Diagnostics, Inc. Rapidly detects GAS antigen from throat swabs and used as an aid in the
Test diagnosis of GAS infection, which typically causes strep throat, tonsillitis,
and scarlet fever
87899QW Meridian Bioscience Immunocard Meridian Bioscience, Inc. Immunoassy for the qualitative detection of Helicobacter pylori antigens in
STAT! HpSA {Stool} stool specimens
87899QW Rapid Pathogen Screening RPS Adeno Rapid Pathogen Screening Immunochromatographic test for the qualitative detection of adenoviral
Detector antigens from eye fluid
87999QW 1. Gryphus Diagnostics BVBlue Gryphus Diagnositcs, LLC Enzyme activity test for use in the detection of vaginal fluid specimens for
sialidase activity, an enzyme produced by bacterial pathogens such as
Gardnerella vaginais, Bacteroides spp., Prevotella spp., and Mobiluncus
spp.

2. Genzyme Diagnostics OSOM Gryphus Diagnositcs, LLC


BVBlue Test
89300QW(This test Embryotech Laboratories Embryotech Laboratories, Screening test to measure sperm concentration
may not be covered FertilMARQ™ Home Diagnostic Inc.
in all instances. Screening Test for Male Infertility
Contact your
Medicare carrier for
claims instructions
89321QW Fertell Male Fertility Test* Genosis Ltd. Determines whether the concentration of motile sperm is above a cut-off
level of 10 million motile sperm cells per ml

This list includes updates from Change Request 5715 27


* Newly added waived test system