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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
Turklab Rapidan Optima Early Test One Step hCG Urine Pregnancy Test for Home Use  
K081150 Urine hCG By Visual Color Comparison Tests Endocrinology 07/01/2009
Turklab Toyo Diagnostics One Step hCG Urine Pregnancy Cassette Test  
K081150 Urine hCG By Visual Color Comparison Tests Endocrinology 07/01/2009
Turklab Toyo Diagnostics One Step hCG Urine Pregnancy Strip Test for Home Use  
K081150 Urine hCG By Visual Color Comparison Tests Endocrinology 07/01/2009
Tyson Bioresearch Inc. Diachex+ Pro Blood Glucose Monitoring System  
K090629 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/08/2009
Tyson Bioresearch Inc. Easy Step Blood Glucose Monitoring System  
K090629 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/08/2009
Twin Spirit, Inc. DrugSmart Cup  
K082898 Amphetamines Toxicology / TDM 05/11/2009
Twin Spirit, Inc. DrugSmart Cup  
K082898 Cannabinoids (THC) Toxicology / TDM 05/11/2009
Twin Spirit, Inc. DrugSmart Cup  
K082898 Phencyclidine (PCP) Toxicology / TDM 05/11/2009
Twin Spirit, Inc. DrugSmart Cup  
K082898 Cocaine Metabolites Toxicology / TDM 05/11/2009
Twin Spirit, Inc. DrugSmart Cup  
K082898 Opiates Toxicology / TDM 05/11/2009
Twin Spirit, Inc. DrugSmart Cup  
K082898 Methadone Toxicology / TDM 05/11/2009
Twin Spirit, Inc. DrugSmart Cup  
K082898 Methamphetamines Toxicology / TDM 05/11/2009
Twin Spirit, Inc. DrugSmart Cup  
K082898 Benzodiazepines Toxicology / TDM 05/11/2009
Twin Spirit, Inc. DrugSmart Cup  
K082898 Barbiturates Toxicology / TDM 05/11/2009
Twin Spirit, Inc. DrugSmart Cup  
K082898 Tricyclic Antidepressants Toxicology / TDM 05/11/2009
Twin Spirit, Inc. DrugSmart Cup  
K082898 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 05/11/2009
Twin Spirit, Inc. DrugSmart Cup  
K082898 Oxycodone Toxicology / TDM 05/11/2009
The Kroger Co. Kroger Blood Glucose Monitoring System  
K073573 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/30/2009
Tyson Bioresearch, Inc., Diachex+ Evolve Blood Glucose Monitoring System  
K073492 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/18/2008
Taidoc Clever Chek TD-3250C Blood Glucose and Blood Pressure Monitoring System  
K080014 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/18/2008
Taidoc Clever Chek TD-3250D Blood Glucose and Blood Pressure Monitoring System  
K080014 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/18/2008
TaiDoc Technology Corporation U-Right TD-4247 Blood Glucose Monitoring System  
K081957 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/07/2008
Tyson Bioresearch Inc. Diachex Basic Blood Glucose Monitoring System  
K072854 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/30/2008
Tyson Bioresearch Inc. Diachex Superb Blood Glucose Monitoring System  
K072854 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/30/2008
Tyson Bioresearch Inc. Diachex Vigor Blood Glucose Monitoring System  
K072854 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/30/2008
Taidoc Technology ACHTUNG TD-4207 No Code Blood Glucose Monitoring System  
K073494 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/28/2008
Taidoc Technology CLEVER CHEK TD-4209 One-Code Blood Glucose Monitoring System  
K073494 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/28/2008
TaiDoc Technology CLEVER CHEK TD-4222 No Code Blood Glucose Monitoring System  
K073494 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/28/2008
Taidoc Technology CLEVER CHEK TD-4225 No Code Blood Glucose Monitoring System  
K073494 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/28/2008
Taidoc Technology CLEVER CHEK TD-4226 One-Code Blood Glucose Monitoring System  
K073494 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/28/2008
Target Corporation, EasyPRO Plus Blood Glucose Monitoring System  
K063068 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/24/2008
Tyson Bioresearch Inc. Diachex+ Determine Blood Glucose Monitoring System  
K073492 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/14/2008
Tyson Bioresearch, Inc., Diachex+ Infinity Blood Glucose Monitoring System  
K073492 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/14/2008
Tyson Bioresearch, Inc. EZ Scan Plus Blood Glucose Monitoring System  
K072441 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/26/2008
TaiDoc Clever Chek TD-4232 Blood Glucose Monitoring System  
K073119 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/04/2008
TaiDoc Technology Corporation Clever Chek TD-4227 Blood Glucose Monitoring System  
K072784 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/08/2008
Tyson Bioresearch, Inc. Ultimate EZ Smart Plus Blood Glucose Monitoring System  
K052818 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/15/2007
TaiDoc Advocate Redi-Code Blood Glucose Monitoring System  
K072039 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/04/2007
TaiDoc REVOLUTION TD-4229 Blood Glucose Monitoring System  
K072489 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/21/2007
Tyson Bioresearch, Inc. EZ Smart-608 Blood Glucose Monitoring System  
K062829 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/28/2007
Taidoc Technology easi check precise Blood Glucose Monitoring System  
K042005 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/02/2007
TaiDoc Clever Chek Blood Glucose Monitoring System TD-4230  
K070472 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/19/2007
TaiDoc SureChek Blood Glucose Monitoring System  
K070472 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/19/2007
Tyson Bioresearch, Inc. SMARTCHEX Blood Glucose Monitoring System  
K052818 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/07/2007
TaiDoc Advocate Blood Glucose Monitoring System  
K063212 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/31/2007
Teco Diagnostics Microalbumin 2-1 Combo Strip  
K061419 Urine Qualitative Dipstick Protein Urinalysis 01/29/2007
Teco Diagnostics Microalbumin 2-1 Combo Strip  
K061419 Urine Qualitative Dipstick Creatinine Urinalysis 01/29/2007
Taidoc Technology Corporation Clever Chek TD-3213 Blood Glucose Plus Blood Pressure Monitoring System  
K062800 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/18/2007
Taidoc Technology Corporation Clever Chek TD-3215 Blood Glucose Plus Blood Pressure Monitoring System  
K062800 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/18/2007
Taidoc Technology Corporation Clever Chek TD-3217 Blood Glucose Plus Blood Pressure Monitoring System  
K062800 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/18/2007
Taidoc Technology Corporation Clever Chek TD-3250 Blood Glucose Plus Blood Pressure Monitoring System  
K062800 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/18/2007
Taidoc Technology Corporation Dr. T TD-3216 Blood Glucose Plus Blood Pressure Monitoring System   
K062800 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/18/2007
Taidoc Clever Chek Blood Glucose Monitoring System TD-4223  
K063212 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/29/2006
Taidoc Clever Chek Blood Glucose Monitoring System TD-4231  
K063212 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/29/2006
Tyson Bioresearch Inc. DIACHEX Blood Glucose Monitoring System  
K062829 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/20/2006
Teco Rapid Fecal Occult Blood (FOB) Card Test  
K061065 Fecal Occult Blood General Chemistry 08/09/2006
Taidoc Technology easy check TD-4209 Blood Glucose Monitoring System   
K042005 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/30/2006
Tyson Bioresearch, Inc. EZ-Smart-168 Blood Glucose Monitoring System  
K052818 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/30/2006
Taidoc Clever Chek TD-3250 Blood Glucose Plus Blood Pressure Monitoring System  
K061073 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/06/2006
Target Corporation EasyPRO Blood Glucose Mornitoring System  
K031388 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/02/2005
Target Corporation EasyPRO Blood Glucose Mornitoring System  
K020232 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/09/2005
Taidoc Prodigy Blood Glucose Monitoring System  
K051854 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/07/2005
Taidoc Clever Chek TD-3215 Blood Glucose and Blood Pressure Measurement System  
K051936 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/11/2005
Taidoc Dr. T TD-3216 Blood Glucose and Blood Pressure Measurement System  
K051936 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/11/2005
Taidoc Clever Chek Blood Glucose Monitoring System TD-4225  
K051854 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/09/2005
TheraSense FreeStyle 600 Blood Glucose Monitoring System  
K050500 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/30/2005
Taidoc Clever Chek TD-3213 Blood Glucose and Blood Pressure Measurement System  
K042795 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/08/2005
TAIDOC SWIFT CHEK BLOOD GLUCOSE MONITORING SYSTEM  
K042005 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/22/2004
TRINITY BIOTECH UNI-GOLD RECOMBIGEN HIV TEST  (Fingerstick, Venipuncture Whole Blood)
BP030025 HIV-1 Antibody General Immunology 11/05/2004
TAIDOC ACHTUNG TD-4207 GLUCOSE TEST SYSTEM  
K042005 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/10/2004
TAIDOC CLEVER CHEK TD-4209 GLUCOSE TEST SYSTEM  
K042005 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/10/2004
TAIDOC CLEVER CHEK TD-4222 GLUCOSE TEST SYSTEM  
K042005 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/10/2004
THYROTEC INC. THYROTEST WHOLE BLOOD TSH TEST  
K030912 Thyroid Stimulating Hormone (TSH) Endocrinology 08/18/2004
TAIDOC CHECK GLUCOSE TEST SYSTEM  
K041107 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/23/2004
TRINITY BIOTECH UNI-GOLD RECOMBIGEN HIV TEST  (WHOLE BLOOD (VENIPUNCTURE))
BP030025 HIV-1 Antibody General Immunology 06/23/2004
TOTAL DIAGNOSTIC SALES, INC. TEST TIME HOME GLUCOSE TEST  
K943503 Glucose General Chemistry 06/07/2004
The Medicine Shoppe Truetrack Smart System, Blood Glucose Monitoring System  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/22/2003
TECO DIAGNOSTICS, URS-1P (PROTEIN TEST)  
K023172 Urine Qualitative Dipstick Protein Urinalysis 06/05/2003
TECO DIAGNOSTICS URS-1N (NITRITE TEST)  
K023325 Urine Qualitative Dipstick Nitrite Urinalysis 05/15/2003
TECO DIAGNOSTICS, URINE REAGENT STRIPS (URS-1B) TESTS FOR BLOOD  
K023297 Urine Qualitative Dipstick Blood Urinalysis 05/15/2003
TECO DIAGNOSTICS, URINE REAGENT STRIPS (URS-1B) TESTS FOR BLOOD  
K023297 Urine Qualitative Dipstick Blood Urinalysis 03/06/2003
TECO DIAGNOSTICS URS-1N (NITRITE TEST)  
K023325 Urine Qualitative Dipstick Nitrite Urinalysis 02/28/2003
TECO DIAGNOSTICS, URS-1P (PROTEIN TEST)  
K023172 Urine Qualitative Dipstick Protein Urinalysis 02/28/2003
TECO DIAGNOSTICS URINE REAGENT STRIPS (URS-1G)  
K020175 Urine Qualitative Dipstick Glucose Urinalysis 03/21/2002
THERMO BIOSTAR ACCEAVA HCG COMBO URINE/SERUM TEST  
K964155 Urine hCG By Visual Color Comparison Tests Endocrinology 03/21/2002
THERASENSE FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM  
K012014 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/25/2002
TCI OVULATION TESTER  
K013323 Fern Test, Saliva Endocrinology 12/05/2001
THERASENSE FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM  
K992684 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/22/2001
TECO DIAGNOSTICS URS-1K URINE REAGENT STRIPS  (Over-The-Counter)
K003987 Ketone, Urine General Chemistry 04/30/2001
THERASENSE FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM  
K000582 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/19/2000
TRUE CARE BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/29/2000
TRINITY BIOTECH UNI-GOLD H. PYLORI  
K991697 Helicobacter Pylori Antibodies General Immunology 07/11/2000
TECO DIAGNOSTICS URITEK TC-101 URINE STRIP READER  
X000001 Urine Qualitative Dipstick Chemistries Urinalysis 03/10/2000
TECO DIAGNOSTICS URS-1K URINE REAGENT STRIPS  
X000002 Urine Qualitative Dipstick Ketone Urinalysis 03/10/2000
 
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