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CLIA - Tests waived by FDA from January 2000 to present

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Tests can be categorized as "waived" from regulatory oversite if they meet certain requirements established by the Clinical Laboratory Improvement Amendments of 1988 (CLIA) law. By selecting a Test System Name, you can view the CLIA data for that Test System, including the corresponding 510(K) record, if applicable. The information is sorted first by the date of Categorization of the Test, then by Test System Name. This list does not include Test Systems that were characterized by the CDC prior to January 2000.
 
 
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Show All Test Systems Download Files | More About CLIA
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Wiener Laboratories Urine Strip  
K083724 Urine Qualitative Dipstick Ketone Urinalysis 09/09/2009
Wiener Laboratories Urine Strip  
K083724 Urine Qualitative Dipstick Bilirubin Urinalysis 09/09/2009
Wiener Laboratories Urine Strip  
K083724 Urine Qualitative Dipstick Blood Urinalysis 09/09/2009
Wiener Laboratories Urine Strip  
K083724 Urine Qualitative Dipstick Glucose Urinalysis 09/09/2009
Wiener Laboratories Urine Strip  
K083724 Urine Qualitative Dipstick Leukocytes Urinalysis 09/09/2009
Wiener Laboratories Urine Strip  
K083724 Urine Qualitative Dipstick Nitrite Urinalysis 09/09/2009
Wiener Laboratories Urine Strip  
K083724 Urine Qualitative Dipstick pH Urinalysis 09/09/2009
Wiener Laboratories Urine Strip  
K083724 Urine Qualitative Dipstick Protein Urinalysis 09/09/2009
Wiener Laboratories Urine Strip  
K083724 Urine Qualitative Dipstick Urobilinogen Urinalysis 09/09/2009
Wiener Laboratories Urine Strip  
K083724 Urine Qualitative Dipstick Specific Gravity Urinalysis 09/09/2009
Wiener Laboratories Urine Strip  
K083724 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 09/09/2009
Wako APOLOWAKO Analyzer {Whole Blood} 
K080123 Glucose General Chemistry 10/31/2008
Wako APOLOWAKO Analyzer {Whole Blood} 
K080123 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 10/31/2008
Wako APOLOWAKO Analyzer  (Whole Blood)
K080125 Triglyceride General Chemistry 10/31/2008
Wako APOLOWAKO Analyzer  (Whole Blood)
K080125 Cholesterol General Chemistry 10/31/2008
Wolfe Drug Testing RealityCheck Integrated Specimen Cup  
K050878 Amphetamines Toxicology / TDM 12/28/2006
Wolfe Drug Testing RealityCheck Integrated Specimen Cup  
K050878 Cannabinoids (THC) Toxicology / TDM 12/28/2006
Wolfe Drug Testing RealityCheck Integrated Specimen Cup  
K050878 Phencyclidine (PCP) Toxicology / TDM 12/28/2006
Wolfe Drug Testing RealityCheck Integrated Specimen Cup  
K050878 Cocaine Metabolites Toxicology / TDM 12/28/2006
Wolfe Drug Testing RealityCheck Integrated Specimen Cup  
K050878 Opiates Toxicology / TDM 12/28/2006
Wolfe Drug Testing RealityCheck Integrated Specimen Cup  
K050878 Methamphetamines Toxicology / TDM 12/28/2006
Wolfe Drug Testing RealityCheck Integrated Specimen Cup  
K050878 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 12/28/2006
WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup  
K050878 Amphetamines Toxicology / TDM 08/21/2006
WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup  
K050878 Cannabinoids (THC) Toxicology / TDM 08/21/2006
WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup  
K050878 Phencyclidine (PCP) Toxicology / TDM 08/21/2006
WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup  
K050878 Cocaine Metabolites Toxicology / TDM 08/21/2006
WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup  
K050878 Opiates Toxicology / TDM 08/21/2006
WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup  
K050878 Methamphetamine/Amphetamine Toxicology / TDM 08/21/2006
WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup  
K050878 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 08/21/2006
WayPoint Biomedical Inc. Health Essist Home Drug Test Marijuana and Cocaine  
K050936 Cocaine Metabolites Toxicology / TDM 08/08/2006
Waypoint Biomedical, Inc. Health Essist Home Drug Test Marijuana and Cocaine  
K050936 Cannabinoids (THC) Toxicology / TDM 08/08/2006
Worldwide Medical First Check Multi Drug Cup 7  (OTC)
K051966 Amphetamines Toxicology / TDM 11/29/2005
Worldwide Medical First Check Multi Drug Cup 7  (OTC)
K051966 Cannabinoids (THC) Toxicology / TDM 11/29/2005
Worldwide Medical First Check Multi Drug Cup 7  (OTC)
K051966 Phencyclidine (PCP) Toxicology / TDM 11/29/2005
Worldwide Medical First Check Multi Drug Cup 7  (OTC)
K051966 Cocaine Metabolites Toxicology / TDM 11/29/2005
Worldwide Medical First Check Multi Drug Cup 7  (OTC)
K051966 Opiates Toxicology / TDM 11/29/2005
Worldwide Medical First Check Multi Drug Cup 7  (OTC)
K051966 Methamphetamines Toxicology / TDM 11/29/2005
Worldwide Medical First Check Multi Drug Cup 7  (OTC)
K051966 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 11/29/2005
Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters  
K993850 Urine Qualitative Dipstick Ketone Urinalysis 09/12/2005
Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters  
K993850 Urine Qualitative Dipstick Bilirubin Urinalysis 09/12/2005
Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters  
K993850 Urine Qualitative Dipstick Blood Urinalysis 09/12/2005
Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 09/12/2005
Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters  
K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 09/12/2005
Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters  
K993850 Urine Qualitative Dipstick Nitrite Urinalysis 09/12/2005
Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters  
K993850 Urine Qualitative Dipstick pH Urinalysis 09/12/2005
Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters  
K993850 Urine Qualitative Dipstick Protein Urinalysis 09/12/2005
Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters  
K993850 Urine Qualitative Dipstick Urobilinogen Urinalysis 09/12/2005
Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters  
K993850 Urine Qualitative Dipstick Specific Gravity Urinalysis 09/12/2005
Walgreens Sidekick Blood Glucose Test System  (Over-The-Counter)
K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/09/2005
WH Accu Test One-Step Urine/Serum Pregnancy Test  
K051841 Urine hCG By Visual Color Comparison Tests Endocrinology 08/22/2005
Wampole Laboratories Clearview hCG II  
K953988 Urine hCG By Visual Color Comparison Tests Endocrinology 08/01/2005
Wampole Laboratories Clearview hCG Combo  
K992187 Urine hCG By Visual Color Comparison Tests Endocrinology 06/10/2005
Wampole Laboratories Clearview hCG Combo with Reference Line  
K992187 Urine hCG By Visual Color Comparison Tests Endocrinology 06/10/2005
Wampole Laboratories Clearview hCG II (Dipstick)  
K954444 Urine hCG By Visual Color Comparison Tests Endocrinology 06/03/2005
Wampole Laboratories Clearview LH Ovulation Test  
K924903 Ovulation Test (LH) By Visual Color Comparison Endocrinology 05/18/2005
Wampole Laboratories Clearview RSV  
K021789 Respiratory Syncytial Virus Virology 04/11/2005
Wondfo One Step HCG Urine Pregnancy Test  
K043443 Urine hCG By Visual Color Comparison Tests Endocrinology 04/08/2005
Walgreens Blood Glucose Monitor, TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
Winn-Dixie Stores Inc. (WD) TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
WAMPOLE LABORATORIES CLEARVIEW H. PYLORI II  (finger stick or whole blood)
K990892 Helicobacter Pylori Antibodies General Immunology 03/08/2005
W.H.P.M. ONE-STEP PREGNANCY TEST  
K041273 Urine hCG By Visual Color Comparison Tests Endocrinology 06/08/2004
Walgreens Blood Glucose System, Truetrack Smart System  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/22/2003
WAMPOLE PREVUE HCG CASSETTE URINE OR SERUM  
K992187 Urine hCG By Visual Color Comparison Tests Endocrinology 05/01/2003
WORLDWIDE MEDICAL CORPORATION FIRST CHECK HOME DRUG TEST  
K020869 Amphetamines Toxicology / TDM 06/13/2002
WAMPOLE PREVUE HCG STICK URINE OR SERUM  
K925303 Urine hCG By Visual Color Comparison Tests Endocrinology 06/12/2002
WAMPOLE PREVUE HCG CASSETTE URINE OR SERUM  
K925125 Urine hCG By Visual Color Comparison Tests Endocrinology 06/07/2002
W.H.P.M. WH ACCU TEST PREGNANCY TEST  
K012284 Urine hCG By Visual Color Comparison Tests Endocrinology 08/29/2001
WAMPOLE PREVUE B. BURGDORFERI  
K981913 Lyme Disease Antibodies (Borrelia Burgdorferi Abs) General Immunology 06/19/2001
WEIS PHARMACY BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/22/2001
WORLDWIDE MEDICAL CORPORATION FIRST CHECK HOME DRUG TEST (THC-COC-OPI-MET)  
K993852 Cannabinoids (THC) Toxicology / TDM 12/06/2000
WORLDWIDE MEDICAL CORPORATION FIRST CHECK HOME DRUG TEST (THC-COC-OPI-MET)  
K993852 Cocaine Metabolites Toxicology / TDM 12/06/2000
WORLDWIDE MEDICAL CORPORATION FIRST CHECK HOME DRUG TEST (THC-COC-OPI-MET)  
K993852 Opiates Toxicology / TDM 12/06/2000
WORLDWIDE MEDICAL CORPORATION FIRST CHECK HOME DRUG TEST (THC-COC-OPI-MET)  
K993852 Methamphetamines Toxicology / TDM 12/06/2000
WYNTEK DIAGNOSTICS SIGNIFY MONO TEST  (For whole blood)
K972231 Infectious Mononucleosis Antibodies (Mono) General Immunology 09/07/2000
WORLDWIDE MEDICAL CORPORATION FIRST CHECK HOME DRUG TEST (THC)  
K993663 Cannabinoids (THC) Toxicology / TDM 07/11/2000
WYNTEK DIAGNOSTICS OSOM ULTRA STREP A  
K992658 Streptococcus, Group A Bacteriology 07/06/2000
WORLDWIDE MEDICAL CORPORATION FIRST CHECK HOME DRUG TEST (THC-COC-MET)  
K994138 Cannabinoids (THC) Toxicology / TDM 06/29/2000
WORLDWIDE MEDICAL CORPORATION FIRST CHECK HOME DRUG TEST (THC-COC-MET)  
K994138 Cocaine Metabolites Toxicology / TDM 06/29/2000
WORLDWIDE MEDICAL CORPORATION FIRST CHECK HOME DRUG TEST (THC-COC-MET)  
K994138 Methamphetamines Toxicology / TDM 06/29/2000
WORLDWIDE MEDICAL FIRST CHECK PANEL 2 (THC/COC)  
K994139 Cannabinoids (THC) Toxicology / TDM 06/29/2000
WORLDWIDE MEDICAL FIRST CHECK PANEL 2 (THC/COC)  
K994139 Cocaine Metabolites Toxicology / TDM 06/29/2000
WYNTEK DIAGNOSTICS SIGNIFY HCG URINE TEST  
K974159 Urine hCG By Visual Color Comparison Tests Endocrinology 05/02/2000
 
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