Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
-

CLIA - Tests waived by FDA from January 2000 to present

see related
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.
 
 
 1 
 3 
 A 
 B 
 C 
 D 
 E 
 F 
 G 
 H 
 I 
 J 
 K 
 L 
 M 
 N 
 O 
 P 
 Q 
 R 
 S 
 T 
 U 
 V 
 W 
 Y 
 Z 
 
 
Show All Test Systems Download Files | More About CLIA
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Siemens Clinitek 50 Urine Chemistry Analyzer  
K960546 Urine Qualitative Dipstick Ketone Urinalysis 09/14/2009
Siemens Clinitek 50 Urine Chemistry Analyzer  
K960546 Urine Qualitative Dipstick Bilirubin Urinalysis 09/14/2009
Siemens Clinitek 50 Urine Chemistry Analyzer  
K960546 Urine Qualitative Dipstick Blood Urinalysis 09/14/2009
Siemens Clinitek 50 Urine Chemistry Analyzer  
K960546 Urine Qualitative Dipstick Glucose Urinalysis 09/14/2009
Siemens Clinitek 50 Urine Chemistry Analyzer  
K960546 Urine Qualitative Dipstick Leukocytes Urinalysis 09/14/2009
Siemens Clinitek 50 Urine Chemistry Analyzer  
K960546 Urine Qualitative Dipstick Nitrite Urinalysis 09/14/2009
Siemens Clinitek 50 Urine Chemistry Analyzer  
K960546 Urine Qualitative Dipstick pH Urinalysis 09/14/2009
Siemens Clinitek 50 Urine Chemistry Analyzer  
K960546 Urine Qualitative Dipstick Protein Urinalysis 09/14/2009
Siemens Clinitek 50 Urine Chemistry Analyzer  
K960546 Urine Qualitative Dipstick Urobilinogen Urinalysis 09/14/2009
Siemens Clinitek 50 Urine Chemistry Analyzer  
K960546 Urine Qualitative Dipstick Specific Gravity Urinalysis 09/14/2009
Siemens Clinitek 50 Urine Chemistry Analyzer  
K972706 Microalbumin General Chemistry 09/14/2009
Siemens Clinitek 50 Urine Chemistry Analyzer  
K972706 Creatinine General Chemistry 09/14/2009
SCI International, Inc. Baby Test Pregnancy Test Cassette Format  
K050741 Urine hCG By Visual Color Comparison Tests Endocrinology 09/09/2009
SCI International, Inc. U-Check Pregnancy Test Cassette Format  
K050741 Urine hCG By Visual Color Comparison Tests Endocrinology 09/09/2009
Specialty Medical Supplies Vocal Point Blood Glucose Monitoring System  
K083570 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/09/2009
Sacks Medical Corp., RefuAH Plus Blood Glucose Monitoring System  
K090057 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/01/2009
Sacks Medical Corporation RefuAH Urinalysis Reagent Strips  
K061559 Urine Qualitative Dipstick Ketone Urinalysis 08/24/2009
Sacks Medical Corporation RefuAH Urinalysis Reagent Strips  
K061559 Urine Qualitative Dipstick Bilirubin Urinalysis 08/24/2009
Sacks Medical Corporation RefuAH Urinalysis Reagent Strips  
K061559 Urine Qualitative Dipstick Blood Urinalysis 08/24/2009
Sacks Medical Corporation RefuAH Urinalysis Reagent Strips  
K061559 Urine Qualitative Dipstick Glucose Urinalysis 08/24/2009
Sacks Medical Corporation RefuAH Urinalysis Reagent Strips  
K061559 Urine Qualitative Dipstick Leukocytes Urinalysis 08/24/2009
Sacks Medical Corporation RefuAH Urinalysis Reagent Strips  
K061559 Urine Qualitative Dipstick Nitrite Urinalysis 08/24/2009
Sacks Medical Corporation RefuAH Urinalysis Reagent Strips  
K061559 Urine Qualitative Dipstick pH Urinalysis 08/24/2009
Sacks Medical Corporation RefuAH Urinalysis Reagent Strips  
K061559 Urine Qualitative Dipstick Protein Urinalysis 08/24/2009
Sacks Medical Corporation RefuAH Urinalysis Reagent Strips  
K061559 Urine Qualitative Dipstick Urobilinogen Urinalysis 08/24/2009
Sacks Medical Corporation RefuAH Urinalysis Reagent Strips  
K061559 Urine Qualitative Dipstick Specific Gravity Urinalysis 08/24/2009
Sacks Medical Corporation RefuAH Urinalysis Reagent Strips  
K061559 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 08/24/2009
Stanbio HemoPoint H2 DM Hemoglobin Measurement System {with Data Management} 
K090093 Hemoglobin Hematology 06/12/2009
Siemens Clinitek Status Urine Chemistry Analyzer  
K031947 Urine Qualitative Dipstick Ketone Urinalysis 03/05/2009
Siemens Clinitek Status Urine Chemistry Analyzer  
K031947 Microalbumin General Chemistry 03/05/2009
Siemens Clinitek Status Urine Chemistry Analyzer  
K031947 Urine Qualitative Dipstick Bilirubin Urinalysis 03/05/2009
Siemens Clinitek Status Urine Chemistry Analyzer  
K031947 Urine Qualitative Dipstick Blood Urinalysis 03/05/2009
Siemens Clinitek Status Urine Chemistry Analyzer  
K031947 Urine Qualitative Dipstick Glucose Urinalysis 03/05/2009
Siemens Clinitek Status Urine Chemistry Analyzer  
K031947 Urine Qualitative Dipstick Leukocytes Urinalysis 03/05/2009
Siemens Clinitek Status Urine Chemistry Analyzer  
K031947 Urine Qualitative Dipstick Nitrite Urinalysis 03/05/2009
Siemens Clinitek Status Urine Chemistry Analyzer  
K031947 Urine Qualitative Dipstick pH Urinalysis 03/05/2009
Siemens Clinitek Status Urine Chemistry Analyzer  
K031947 Urine Qualitative Dipstick Protein Urinalysis 03/05/2009
Siemens Clinitek Status Urine Chemistry Analyzer  
K031947 Urine Qualitative Dipstick Specific Gravity Urinalysis 03/05/2009
Siemens Clinitek Status Urine Chemistry Analyzer  
K031947 Urine Qualitative Dipstick Creatinine Urinalysis 03/05/2009
Siemens Clinitek Status Urine Chemistry Analyzer  
K032563 hCG, Urine Endocrinology 01/26/2009
Syntron Bioresearch Quikscreen Multiple Drug Cup Test  (Professional version)
K071489 Amphetamines Toxicology / TDM 01/07/2009
Syntron Bioresearch Quikscreen Multiple Drug Cup Test  (Professional version)
K071489 Cannabinoids (THC) Toxicology / TDM 01/07/2009
Syntron Bioresearch Quikscreen Multiple Drug Cup Test  (Professional version)
K071489 Phencyclidine (PCP) Toxicology / TDM 01/07/2009
Syntron Bioresearch Quikscreen Multiple Drug Cup Test  (Professional version)
K071489 Cocaine Metabolites Toxicology / TDM 01/07/2009
Syntron Bioresearch Quikscreen Multiple Drug Cup Test  (Professional version)
K071489 Methadone Toxicology / TDM 01/07/2009
Syntron Bioresearch Quikscreen Multiple Drug Cup Test  (Professional version)
K071489 Methamphetamines Toxicology / TDM 01/07/2009
Syntron Bioresearch Quikscreen Multiple Drug Cup Test  (Professional version)
K071489 Benzodiazepines Toxicology / TDM 01/07/2009
Syntron Bioresearch Quikscreen Multiple Drug Cup Test  (Professional version)
K071489 Barbiturates Toxicology / TDM 01/07/2009
Syntron Bioresearch Quikscreen Multiple Drug Cup Test  (Professional version)
K071489 Morphine Toxicology / TDM 01/07/2009
Syntron Bioresearch Quikscreen Multiple Drug Cup Test  (Professional version)
K071489 Tricyclic Antidepressants Toxicology / TDM 01/07/2009
Syntron Bioresearch Quikscreen Multiple Drug Cup Test  (Professional version)
K071489 Oxycodone Toxicology / TDM 01/07/2009
SCI International Inc. New Choice Pro hCG Pregnancy Test Cassette Format  
K050741 Urine hCG By Visual Color Comparison Tests Endocrinology 01/05/2009
SCI International Inc. New Choice Pro Pregnancy Test Strip Format  
K951705 Urine hCG By Visual Color Comparison Tests Endocrinology 01/05/2009
SCI International Inc. New Choice Pro hCG Pregnancy Test 2000 mIU/mL Cassette Format  
K052694 Urine hCG By Visual Color Comparison Tests Endocrinology 12/17/2008
Siemens DCA 2000 analyzer  
K951361 Glycated Hemoglobin, Total General Chemistry 11/13/2008
Siemens DCA 2000+ analyzer  
K951361 Glycated Hemoglobin, Total General Chemistry 11/13/2008
Simple Diagnostics Clever Chek Auto-Code Voice Blood Glucose Monitoring System  
K081144 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/23/2008
SpermCheck Vasectomy  
K073039 Semen Hematology 06/12/2008
Specialty Medical Supplies SureChek Edge Blood Glucose Monitoring System  
K080501 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/28/2008
Stanbio Rely Mono Rapid Test  (Whole Blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 01/08/2008
Siemens Medical Diagnostics DCA Vantage Analyzer  
K071466 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 10/11/2007
Signify Mono Cassette  (Whole Blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 07/12/2007
Select Diagnostics Rapid Test Mono Cassette  (Whole Blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 07/02/2007
Select Medical Products Brand Rapid Test H. Pylori {Whole Blood Only} (H. Pylori)
K024350 Helicobacter Pylori Antibodies General Immunology 06/25/2007
Savyon Diagnostics Uriscreen {Bacteriuria} 
K882211 Urine Dipstick Or Tablet Analytes, Nonautomated Urinalysis 06/11/2007
SA Scientific SAS Pregnancy Serum/Urine Test  
K010593 Urine hCG By Visual Color Comparison Tests Endocrinology 05/31/2007
Signify Mono Whole Blood  (Whole Blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 04/12/2007
SA Scientific SAS Pregnancy Urine Test  
K010522 Urine hCG By Visual Color Comparison Tests Endocrinology 03/28/2007
SA Scientific SAS Pregnancy Serum/Urine Test  
K010593 Urine hCG By Visual Color Comparison Tests Endocrinology 03/14/2007
Select Diagnostics Immunochemical Fecal Occult Blood Test  
K060463 Fecal Occult Blood General Chemistry 02/08/2007
Solartek Products, Inc. Kroger Blood Glucose Monitoring System  
K033845 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/01/2006
Solartek Products, Inc. ReliOn Ultima Blood Glucose Monitoring System  
K033845 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/01/2006
Solartek Products, Inc. RiteAid Blood Glucose Monitoring System  
K033845 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/01/2006
Saless Enterprises Inc. One Step LH Ovulation Test Cassette  
X050002 Ovulation Test (LH) By Visual Color Comparison Endocrinology 02/22/2006
Safeway Sidekick Blood Glucose Testing System  
K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/09/2006
Sein Electronics Blood Glucose and Blood Pressure Measurement System, Model BGP-100  
K052108 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/08/2005
SA Scientific SAS Influenza A Test  
K041441 Influenza A Virology 11/23/2005
SA Scientific SAS Influenza B Test  
K041439 Influenza B Virology 11/23/2005
SA Scientific SAS RSV Test  
K022845 Respiratory Syncytial Virus Virology 10/20/2005
SA Scientific SAS RSVAlert  
K022845 Respiratory Syncytial Virus Virology 10/20/2005
Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters)  
K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 03/29/2005
Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters)  
K993850 Urine Qualitative Dipstick Ketone Urinalysis 03/29/2005
Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters)  
K993850 Urine Qualitative Dipstick Bilirubin Urinalysis 03/29/2005
Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters)  
K993850 Urine Qualitative Dipstick Blood Urinalysis 03/29/2005
Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters)  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 03/29/2005
Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters)  
K993850 Urine Qualitative Dipstick Nitrite Urinalysis 03/29/2005
Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters)  
K993850 Urine Qualitative Dipstick pH Urinalysis 03/29/2005
Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters)  
K993850 Urine Qualitative Dipstick Protein Urinalysis 03/29/2005
Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters)  
K993850 Urine Qualitative Dipstick Urobilinogen Urinalysis 03/29/2005
Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters)  
K993850 Urine Qualitative Dipstick Specific Gravity Urinalysis 03/29/2005
Saless Enterprises Inc. One Step hCG Pregnancy Urine Test Strip  
K951705 Urine hCG By Visual Color Comparison Tests Endocrinology 03/16/2005
Saless Enterprises Inc. One Step hCG Pregnancy Urine Test Cassette  
K023638 Urine hCG By Visual Color Comparison Tests Endocrinology 03/16/2005
STANBIO LABORATORY EZ-WELL STREP A RAPID DEVICE TEST  
K023766 Streptococcus, Group A Bacteriology 10/29/2004
Stanbio HemoPoint H2 Hemoglobin Measurement System  
K032482 Hemoglobin Hematology 06/09/2004
SYNOVA HEALTHCARE MENOCHECKPRO  (Professional Use)
K023408 Follicle Stimulating Hormone (FSH) Endocrinology 05/11/2004
SYNOVA HEALTHCARE MENOCHECK MENOPAUSE INDICATOR TEST  
K023408 Follicle Stimulating Hormone (FSH) Endocrinology 02/23/2004
SA SCIENTIFIC SAS STREP A  (direct from throat swab)
K023270 Streptococcus, Group A Bacteriology 02/02/2004
STANDARD DIAGNOSTICS GOOD MORNING TEST  
K031798 Urine hCG By Visual Color Comparison Tests Endocrinology 12/09/2003
SAV-ON OSCO BY ALBERTSON'S TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/22/2003
SACKS BIOLOGICALS AIMSTEP COMBO PREGNANCY  
K981165 Urine hCG By Visual Color Comparison Tests Endocrinology 07/31/2003
SACKS BIOLOGICALS AIMSTEP PREGNANCY  
K980531 Urine hCG By Visual Color Comparison Tests Endocrinology 07/31/2003
SACKS MEDICAL REFUAH STREP A RAPID TEST  
K010582 Streptococcus, Group A Bacteriology 07/08/2003
SACKS MEDICAL CORPORATION REFUAH HCG-COMBO IMMUNOCHEMICAL TEST  
K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 06/17/2003
SACKS MEDICAL CORPORATION REFUAH HCG-URINE IMMUNOCHEMICAL TEST  
K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 06/17/2003
SA SCIENTIFIC SURE-VUE URINE HCG  
K010593 hCG, Urine Endocrinology 05/01/2003
STANBIO QUSTICK STREP A  
K010582 Streptococcus, Group A Bacteriology 03/05/2003
STANBIO TRUE 20 ONE-STEP PREGNANCY TEST  
K980531 Urine hCG By Visual Color Comparison Tests Endocrinology 03/05/2003
SA SCIENTIFIC SAS BLOOD/SERUM/URINE HCG  
K022683 Urine hCG By Visual Color Comparison Tests Endocrinology 12/17/2002
SOLARTEK PRODUCTS, RITE AID BLOOD GLUCOSE MONITORING SYSTEM  
K983504 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/15/2002
SCITECK DIAGNOSTICS BABYCHECK ONE STEP PREGNANCY TEST  
K960174 Urine hCG By Visual Color Comparison Tests Endocrinology 10/18/2002
STESANS MAYBE?MOM MINI OVULATION MICROSCOPE  
K013582 Fern Test, Saliva Endocrinology 08/26/2002
SERIM PYLORITEK VP TEST KIT  
K014038 Helicobacter Pylori Bacteriology 07/25/2002
STANBIO QUPID PLUS E.R. ONE STEP PREGNANCY  
K020378 Urine hCG By Visual Color Comparison Tests Endocrinology 06/19/2002
SA SCIENTIFIC SAS VALUE HCG  
K020438 Urine hCG By Visual Color Comparison Tests Endocrinology 03/08/2002
STANBIO HEMA-SCREEN  
K911075 Fecal Occult Blood General Chemistry 09/27/2001
STARLINE COLOSCAN  
K911075 Fecal Occult Blood General Chemistry 09/27/2001
SA SCIENTIFIC SURE-VUE URINE HCG  
K010522 Urine hCG By Visual Color Comparison Tests Endocrinology 08/23/2001
SAV-ON OSCO BY ALBERTSON'S BLOOD GLUCOSE SYSTEM IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/03/2001
SA SCIENTIFIC SURE VUE SERUM/URINE HCG  
K010593 Urine hCG By Visual Color Comparison Tests Endocrinology 07/27/2001
SA SCIENTIFIC SURE-VUE SERUM/URINE HCG-STAT  
K990684 hCG, Urine Endocrinology 07/03/2001
SA SCIENTIFIC HEB ONE-STEP PREGNANCY TEST  
K991193 hCG, Urine Endocrinology 07/02/2001
SA SCIENTIFIC SAS ULTRA HCG SERUM/URINE  
K990684 Urine hCG By Visual Color Comparison Tests Endocrinology 06/04/2001
STC TECHNOLOGIES ORASURE Q.E.D. A-150 SALIVA ALCOHOL TEST  
K894001 Alcohol, Saliva Toxicology / TDM 01/22/2001
STC TECHNOLOGIES ORASURE Q.E.D. A-350 SALIVA ALCOHOL TEST  
K903235 Alcohol, Saliva Toxicology / TDM 12/19/2000
SENTRY BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/13/2000
SHOP RITE BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/13/2000
SAV-ON OSCO BY ALBERTSON'S BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/29/2000
SELFCARE, INC., FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM  
K001427 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/27/2000
SA SCIENTIFIC SAS SERUM/URINE HCG  
K990684 Urine hCG By Visual Color Comparison Tests Endocrinology 04/26/2000
SELFCARE, INC., FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM  
K000583 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/15/2000
 
-
-
-
-
-