CLIA Waived Tests and CPT Codes
Waived Tests and CPT Codes
This list is for informational purposes only and may not accurately represent current CMS CPT codes. Please verify your tests waived status and CPT code prior to implementing testing.
Test Name/Specific Test System
Manufacturer
Approved CPT
Code(s)
Adenovirus
AdenoPlus (human eye fluid)
Rapid Pathogen Screening, Inc. 87809QW
Quidel, AdenoPlus Test, Adeno Detector, Detecor Plus (Tear Fluid) Quidel Corporation
87809QW
Quidel Corporation, QuickVue Adenoviral Conjunctivitis Test {Tear Fluid}
Quidel Corporation
87809QW
Rapid Pathogen Screening RPS Adeno Detector
Rapid Pathogen Screening, Inc. 87809QW
Aerobic/Anaerobic Organisms - Vaginal
Genzyme Diagnostics OSOM BVBLUE Test Gryphus Diagnostics BVBlue OBGYN-Vph Vaginal Ph Screening Kit
Gryphus Diagnostics, LLC Gryphus Diagnostics, LLC Teco Diagnostics
87905QW 87905QW Pending
Aerobic/Anaerobic/Viral Panel - Respiratory
FilmArray Respiratory Panel 2.0 EZ (RP EZ) (nasopharyngeal)
Biofire Diagnostics, LLC
Pending
Albumin
Abaxis Piccolo Blood Chem Analyzer WB (Chem 13, CMP, Renal) Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc) Abaxis Piccolo xpress Chem Analyzer WB (Chem 13, CMP, Liver Panel Plus, Renal) Arkray SPOTCHEM EZ Chem Analyzer (WB) Genzyme Diag OSOM ImmunoDip (urinary alb) HemoCue Albumin 201 System (urinary albumin) TECO Diagnostics, Albumin Rapid Test Stick and Card
Abaxis, Inc
Abaxis, Inc.
Abaxis, Inc
Polymedco, Inc Genzyme Diagnostics HemoCue AB Teco Diagnotics
82040QW
82040QW
82040QW
82040QW 82040QW 82040QW 82040QW
Alanine Aminotransferase (ALT)
Abaxis Piccolo Blood Chem Analyzer WB (CMP, Chem 6, Chem 13) Abaxis Piccolo Point Of Care Chemistry Analyzer (Lipid Panel Reagent Disc) ALT Abaxis Piccolo xpress Chem Analyzer WB(CMP, Lipid Panel Plus, Liver Panel Plus, Chem 6, Chem 13) Alere Cholestech LDX (ALT)(WB) Arkray SPOTCHEM EZ Chem Analyzer (WB) Cholestech LDX Alanine Aminotransferase (ALT)
Abaxis, Inc
Abaxis, Inc.
Abaxis, Inc Alere, Inc Arkray, Inc. / Polymedco, Inc Cholestech Corporation
84460QW
84460QW
84460QW 84466QW 84460QW 84460QW
Alkaline Phosphatase (ALP)
Abaxis Piccolo Blood Chem Analyzer WB (CMP, Chem 13) Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc) (WB) Abaxis Piccolo xpress Chem Analyzer WB (CMP, Chem 13, Liver Panel Plus) Akray SPOTCHEM EZ Chem Analyzer (WB)
Abaxis, Inc Abaxis, Inc.
Abaxis, Inc Polymedco, Inc
84075QW 84075QW
84075QW 84075QW
Amylase
Abaxis Piccolo Blood Chem Analyzer WB (Chem 13) Abaxis Piccolo express Chemistry Analyzer WB (Liver Panel Plus, Chem 13) Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc)(WB)
Abaxis, Inc Abaxis, Inc
Abaxis, Inc.
82150QW 82150QW
82150QW
DOH 681-018 May 2020
Page 1 of 61
Test Name/Specific Test System
Manufacturer
Aspartate Aminotransferase (AST)
Abaxis Piccolo Blood Chem Analyzer WB (Chem 6, Chem 13, CMP) Abaxis Piccolo Point Of Care Chemistry Analyzer (Liver Panel Reagent Disc) AST (WB) Abaxis Piccolo xpress Chem Analyzer WB(Chem 6, Chem 13, CMP, Liver Panel Plus, Lipid Panel Plus) Arkray SPOTCHEM EZ Chem Analyzer (WB) Cholestech LDX Aspartate Aminotransferase
Abaxis, Inc
Abaxis, Inc.
Abaxis, Inc Arkray, Inc. / Polymedco, Inc Cholestech Corporation
B-Type Natriuretic Peptide (BNP)
Biosite Triage Meter (WB) (BNP) Biosite Triage Meter Plus (WB)(BNP) Biosite Triage Meterpro (WB)(BNP)
Biosite Incorporated Biosite Incorporated Biosite Incorporated
Basic Metabolic Panel (Calcium, Ionized)
Abbott i-STAT CHEM8+ Cartridge WB
I-STAT Corporation
Basic Metabolic Panel (Calcium, Total)
Abaxis Piccolo Blood Chemistry Analyzer WB (Basic Metabolic Reagent Disc) Abaxis Piccolo xpress Chemistry Analyzer WB (Basic Metabolic Reagent Disc)
Abaxis, Inc Abaxis, Inc
Bilirubin, Total
Abaxis Piccolo Blood Chem Analyzer WB (Chem 13, CMP)
Abaxis, Inc
Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc)(WB) Abaxis Piccolo xpress Chem Analyzer WB(Chem 13, CMP, Liver Panel Plus)
Abaxis, Inc. Abaxis, Inc
Akray SPOTCHEM EZ Chem Analyzer (WB)
Polymedco, Inc
Bladder Tumor Associated Antigen
Alere NMP22 BladderChek Test BTA stat Test (for home use) LifeScan Status BTA Maritech BladderCheck
Alere Bion Diagnostic Sciences Polymedco, Inc Maritech, Inc.
BUN (Blood Urea Nitrogen)
Abaxis Piccolo Blood Chemistry Analyzer (Chem 6 and 13 Panels, CMP, BMP, Metlyte 8, Renal)
Abaxis, Inc.
Abaxis Piccolo xpress Chemistry Analyzer WB (Chem 6, 13, Kidney Panels, CMP, BMP, Metlyte 8, Renal)
Abaxis, Inc.
Abbott i-STAT 6+ Cartridge (WB)
i-STAT Corporation
Abbott i-STAT CHEM8+ Cartridge (WB)
i-STAT Corporation
Arkray SPOTCHEM EZ Chem Analyzer (WB)
Arkray, Inc.
Calcium
Abaxis Piccolo Blood Chemistry Analyzer WB (Chem 13 Panel, CMP, BMP, Renal) Abaxis Piccolo xpress Chemistry Analyzer WB (Chem 13 Panel, CMP, BMP, Renal)
Abaxis, Inc. Abaxis, Inc.
Arkray SPOTCHEM EZ Chem Analyzer (WB)
Polymedco, Inc
Calcium ? Ionized
Abbott i-STAT CHEM8+ Cartridge (WB)
i-STAT Corporation
Approved CPT
Code(s)
84450QW 84450QW 84450QW 84450QW 84450QW
83880QW 83880QW 83880QW
80047QW
80048QW 80048QW
82247QW 82247QW 82247QW 82247QW
86386QW 86294QW 86294QW 86386QW
84520QW 84520QW 84520QW 84520QW 84520QW
82310QW 82310QW 82310QW
82330QW
DOH 681-018 May 2020
Page 2 of 61
Test Name/Specific Test System
Manufacturer
Carbon Dioxide (CO2)
Abaxis Piccolo Blood Chemistry Analyzer (CMP, BMP, Electrolyte Discs, Metlyte 8, Renal) Abaxis Piccolo xpress Chemistry Analyzer (CMP, BMP, Electrolyte Discs, Metlyte 8, Renal) Abbott i-STAT CHEM8+ Cartridge (WB)
Abaxis, Inc
Abaxis, Inc i-STAT Corporation
Catalase
Accutest Uriscreen Rapid UTI Screen
Savyon Diagnostics
Uriscreen (for OTC use), urine
Diatech Diagnostics
Chloride
Abaxis Piccolo Blood Chemistry Analyzer (CMP, BMP, Electrolyte, Metlyte 8, Renal) Abaxis Piccolo xpress Chemistry Analyzer (CMP, BMP, Electrolyte, Metlyte 8, Renal)
Abaxis, Inc Abaxis, Inc
Abbott i-STAT 6+ Cartridge (WB)
i-STAT Corporation
Abbott i-STAT CHEM8+ Cartridge (WB)
i-STAT Corporation
Cholesterol
Abaxis Piccolo xpress Chemistry Analyzer {capillary-finger stick} (Cholesterol) Abaxis Piccolo xpress Chemistry Analyzer WB (Lipid Panel, Lipid Panel Plus) Abaxis Piccolo Point of Care Chemistry Analyzer WB (Lipid Panel, Lipid Panel Plus)
Accu-Check InstantPlus Cholesterol Test System
Abaxis, Inc Abaxis, Inc Abaxis, Inc Roche/Boehringer Mannheim
Accucheck Instant Plus Dual Testing System
Roche Diagnostics
ACON Laboratories Inc., Mission Cholesterol Pro Monitoring System
ACON Laboratories, Inc.
Advanced Care Cholesterol Measuring System
Johnson & Johnson
Alere Cholestech LDX (cholesterol)(WB)
Alere, Inc
Alere San Diego, Inc., Cholestech LDX {WB}
Abbott
Arkray SPOTCHEM EZ Chem Analyzer (WB)
Polymedco, Inc
Biomedix Inc Q Steps Biometer G/C Dual Monitoring System
Biomedix, Inc.
ChemTrak AccuMeter Cholesterol Test System
ChemTrak
Cholestech LDX (Must have software version 1.40 or above)
Cholestech
ENA.C.T. Total Cholesterol & PDU
ActiMed Laboratories, Inc
Germaine Laboratories Inc. AimStrip Tandem Lipid Profile and Glucose Measuring System
OSANG Healthcare Co., Ltd.
Infopia USA LipidPro
Infopia Co Ltd
Infopia USA LipidPro Professional Lipid Profile and Glucose Measuring System Jant Pharmacal LipidPlus Lipid Profile and Glucose Measuring System KPI Healthcare Co., Ltd. CURO L5 Lipid Profile and Glucose Measuring System/Test Strips
Infopia Co Ltd Infopia Co, Ltd OSANG Healthcare Co., Ltd.
Lifestream Plus Cholesterol Monitor
Lifestream Technologies
Lifestream Technologies Cholesterol Monitor
Lifestream Technologies
Approved CPT
Code(s)
82374QW
82374QW 82374QW
81007QW 81007QW
82435QW
82435QW 82435QW 82435QW
82465QW
82465QW
82465QW 82465QW 82465QW 82465QW 82465QW 82465QW 82465QW 82465QW 82465QW 82465QW 82465QW 82465QW 82465QW 82465QW 82465QW
82465QW
82465QW 82465QW 82465QW
DOH 681-018 May 2020
Page 3 of 61
Test Name/Specific Test System
Manufacturer
Lifestream Technologies Personal Cholesterol Monitor for cholesterol
Lifestream Technologies, Inc.
Mission Cholesterol Monitoring System
Monitoring System
and
Mission Cholesterol
Pro
ACON Laboratories, INC
Polymer Technology Systems Bioscanner, Bioscanner Plus, and Polymer Technology Systems,
Bioscanner 2000 PTS
Inc
Polymer Technology Systems MTM BioScanner 1000
Polymer Technology Systems, Inc
Polymer Technology Systems Cardiochek Plus, Cardiochek Home
Use, Home Test System, and Cardiochek PA Analyzer test strips. CardioChek Home Chol+HDL+Glu Test strips
-PTS Panels Lipid Panel test strips
Polymer Technology Systems, Inc
Approved CPT
Code(s)
82465QW 82465QW 82465QW 82465QW
82465QW
82947QW
-CardioChek Home Lipid Panel test strips
82947QW
Roche Diagnostics Accutrend Plus System WB
Roche Diagnostics
82465QW
SD Biosensor USA, Inc., SD LipidoCare (BT) Home Lipid Panel Test Strip) SD Biosensor USA, Inc., SD LipidoCare (BT) Professional System (SD LipidoCare Professional Lipid Panel Test Strip)
Wako APOLOWAKO Analyzer
SD BIOSENSOR SD BIOSENSOR Wako Chemicals USA
Pending Pending 82465QW
Complete Blood Count
XW-100 Automated Hematology Analyzer for CLIA Waived Use (Hematocrit, Hemoglobin, Platelet Count, Red blood cell (RBC) count, White blood cell (WBC) count, White blood cell differential)
Sysmex America, Inc
Pending
Comprehensive Metabolic Panel
Abaxis Piccolo Blood Chemistry Analyzer WB (Comprehensive Metabolic Reagent Disc) Abaxis Piccolo xpress Chemistry Analyzer WB (Comprehensive Metabolic Reagent Disc)
Abaxis, Inc Abaxis, Inc
80053QW 80053QW
Creatine Kinase (CK)
Abaxis Piccolo Blood Chemistry Analyzer WB (Metlyte 8 Disc) Abaxis Piccolo xpress Chemistry Analyzer WB (Metlyte 8 Disc)
Abaxis, Inc Abaxis, Inc
82550QW 82550QW
Creatinine
Abaxis Piccolo Blood Chem Analyzer WB (Chem 6 and 13 Panels, CMP, BMP, Metlyte 8, Renal)
Abaxis, Inc.
Abaxis Piccolo xpress Chem Analyzer WB (Chem 6, 13, Kidney Panels, CMP, BMP, Metlyte 8, Renal)
Abaxis, Inc.
Abbott i-STAT Crea Cartridge (WB)
i-STAT Corporation
Abbott i-STAT CHEM8+ Cartridge (WB)
i-STAT Corporation
Akray SPOTCHEM EX Chem Analyzer (WB)
Polymedco, Inc
Siemens Clinitek 50 Urine Chemistry Analyzer (see also under Urinalysis)
Bayer
Siemens MICROABLUSTIX Reagent Strips
Bayer
Siemens MultiStix PRO 10LS, PRO 11 and PRO 7G Reagent Strips (urine dipstick and urine creatinine nonautomated)
Bayer
82565QW
82565QW 82565QW 82565QW 82565QW 82570QW 82570QW 82570QW
Drugs of Abuse (Use G0477QW for visually read devices or G0478QW for instrument read devices)
1 Step Detect Associates DTX Drug Test Cup Integrated E-Z Split
Key Cup II(amphetamines, cocaine metabolites, MDMA,
Biosite Inc
methamphetamines, opiates, PCP, THC)
80305QW
DOH 681-018 May 2020
Page 4 of 61
Test Name/Specific Test System
Manufacturer
12 Panel Now (DBA) Hospital Connect Inc, 12 Panel Dip/Cup Tests
(amphetamines, barbiturates, buprenorphine, benzodiazepines, cocaine metabolites, EDDP, MDMA, methamphetamines, morphine, methadone, oxycodone, PCP, propoxyphene, tricyclic
Assure Tech (Hangzhou) Co., Ltd.
antidepressants, THC)
Abbott Diagnostics Signify ER Drug Screen Test(amphetamines,
barbiturates, benzodiazepines,cocaine metabolites, MDMA, opiates, Innovacon, Inc
oxycodone, PCP, propoxyphene, THC, tricyclic antidepressants)
Acon iCassette Multi-Drug, Multi-Line Screen Test Device
(amphetamines, cocaine metabolites, methamphetamines, opiates , Acon Laboratories, Inc. PCP, THC)
Acon Multi-Drug, Multi-Line Screen Test Card with Integrated Cup
{professional use}(amphetamines, cocaine metabolites, MDMA Acon Laboratories, Inc.
methamphetamines, opiates, PCP, THC)
Acon On Call Multi Drug Home Test/Test Cup(amphetamines, cocaine metabolites, methamphetamines, opiates, PCP,THC)
Acon Laboratories, Inc.
Acon One Step Multi-Drug, Multi-Line Screen Test Device
P{professional use}(amphetamines, cocaine metabolites,
Acon Laboratories, Inc.
methamphetamines, opiates, PCP, THC)
Acon Redi-Test Cassette Multi-Drug, Multi-Line Screen Test Device
(amphetamines, cocaine metabolites, methamphetamines, opiates, Acon Laboratories, Inc.
PCP, THC)
Accu-Stat Drugs of abuse Home Test amphetamines, cocaine metabolites, methamphetamines, opiates, PCP,THC)
Accu-Stat Diagnostics, Inc.
Accu-Stat Home Drug Test
-Cocaine
-Marijuana -Marijuana and Cocaine -Marijuana, cocaine, amphetamine,
Accu-Stat Diagnostics, Inc.
-Methamphetamine, opiates, PCP
-Marijuana, cocaine, amphetamine,
-Methamphetamine, opiates, ecstasy, PCP
ACCU News Drug Screening Test Card/Urine Cup (Amphetamines, Methamphetamines, Opiates, Cocaine Metabolites, Cannabinoids)
Coretests, Inc
ADC Multiple Drug Test Card (opiates, methamphetamines, cocaine metabolites, THC, PCP)
Advantage Diagnostics Corp
Accutest Multi-Drug, Multi Line Screen Test Device (amphetamines, THC, cocaine metabolites, methamphetamines. Opiates, (PCP)
Acon
Laboratories, Inc.
Advin Multi-Drug Screen Test (amphetamines, barbiturates,
buprenorphine, benzodiazepines, cocaine, metabolites, EDDP, methamphetamines, morphine, methadone, opiates, oxycodone,
Advin Biotech
PCP, tricyclic antidepressants, THC, MDMA)
Aeon Multi-Drug Urine Test Cup and DipCard (amphetamines, barbituates, benzodiapzepines, buprenorphine, THC, cocaine metabolites, methadone, MDMA, methamphetamines, morphine,
Healgen Scientific Limited
oxycodone, PCP, tricyclic antidepressants, EDDP)
AimScreen Multi-Drug Urine Dip Card, Dip Device CLIA Waived
and Test Cup (Amphetamines, Benzodiazepines, Cocaine metaboities, Cannabinoids, Methamphetamines, Oxycodone,
Healgen Scientific Limitied
Morphine, Barbituates, Buprenorphine, MDMA, PCP, Methadone)
Alatex Scientific Peace of Mind Marijuana Home Drug Test
Advantage Diagnostics Corp
Approved CPT
Code(s)
80305QW
80305QW 80305QW 80305QW 80305QW 80305QW 80305QW 80305QW
80305QW
80305QW 80305QW 80305QW 80305QW
80305QW
80305QW 80305QW
DOH 681-018 May 2020
Page 5 of 61
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