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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
Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips  
K991927 Urine Qualitative Dipstick Ketone Urinalysis 01/05/2009
Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips  
K991927 Urine Qualitative Dipstick Bilirubin Urinalysis 01/05/2009
Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips  
K991927 Urine Qualitative Dipstick Blood Urinalysis 01/05/2009
Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips  
K991927 Urine Qualitative Dipstick Glucose Urinalysis 01/05/2009
Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips  
K991927 Urine Qualitative Dipstick Leukocytes Urinalysis 01/05/2009
Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips  
K991927 Urine Qualitative Dipstick Nitrite Urinalysis 01/05/2009
Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips  
K991927 Urine Qualitative Dipstick pH Urinalysis 01/05/2009
Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips  
K991927 Urine Qualitative Dipstick Protein Urinalysis 01/05/2009
Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips  
K991927 Urine Qualitative Dipstick Urobilinogen Urinalysis 01/05/2009
Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips  
K991927 Urine Qualitative Dipstick Specific Gravity Urinalysis 01/05/2009
Jant Pharmacal Corporation Accustrip URS Reader  
K061742 Urine Qualitative Dipstick Ketone Urinalysis 01/05/2009
Jant Pharmacal Corporation Accustrip URS Reader  
K061742 Urine Qualitative Dipstick Bilirubin Urinalysis 01/05/2009
Jant Pharmacal Corporation Accustrip URS Reader  
K061742 Urine Qualitative Dipstick Blood Urinalysis 01/05/2009
Jant Pharmacal Corporation Accustrip URS Reader  
K061742 Urine Qualitative Dipstick Glucose Urinalysis 01/05/2009
Jant Pharmacal Corporation Accustrip URS Reader  
K061742 Urine Qualitative Dipstick Leukocytes Urinalysis 01/05/2009
Jant Pharmacal Corporation Accustrip URS Reader  
K061742 Urine Qualitative Dipstick Nitrite Urinalysis 01/05/2009
Jant Pharmacal Corporation Accustrip URS Reader  
K061742 Urine Qualitative Dipstick pH Urinalysis 01/05/2009
Jant Pharmacal Corporation Accustrip URS Reader  
K061742 Urine Qualitative Dipstick Protein Urinalysis 01/05/2009
Jant Pharmacal Corporation Accustrip URS Reader  
K061742 Urine Qualitative Dipstick Urobilinogen Urinalysis 01/05/2009
Jant Pharmacal Corporation Accustrip URS Reader  
K061742 Urine Qualitative Dipstick Specific Gravity Urinalysis 01/05/2009
Jant Pharmacal Accutest Dual Sample Immunological Fecal Occult Blood (iFOB) Test  
K073431 Fecal Occult Blood General Chemistry 12/04/2008
Jant Pharmacal Accutest Immunological Fecal Occult Blood Test (iFOBT)  
K063693 Fecal Occult Blood General Chemistry 12/04/2008
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K052719 Urine Qualitative Dipstick Ketone Urinalysis 09/18/2008
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K052719 Urine Qualitative Dipstick Bilirubin Urinalysis 09/18/2008
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K052719 Urine Qualitative Dipstick Blood Urinalysis 09/18/2008
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K052719 Urine Qualitative Dipstick Glucose Urinalysis 09/18/2008
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K052719 Urine Qualitative Dipstick Leukocytes Urinalysis 09/18/2008
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K052719 Urine Qualitative Dipstick Nitrite Urinalysis 09/18/2008
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K052719 Urine Qualitative Dipstick pH Urinalysis 09/18/2008
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K052719 Urine Qualitative Dipstick Protein Urinalysis 09/18/2008
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K052719 Urine Qualitative Dipstick Urobilinogen Urinalysis 09/18/2008
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K052719 Urine Qualitative Dipstick Specific Gravity Urinalysis 09/18/2008
Jant Pharmacal Accutest Integrated Strep A Rapid Test Device {Strep A} 
K023766 Streptococcus, Group A Bacteriology 03/19/2008
JANT Pharmacal Corporation Accutest Value + Urine Pregnancy Test Device  
K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 01/30/2008
Jant Pharmacal Accutest Value + Mononucleosis Rapid Test  (Whole Blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 01/08/2008
Jant Pharmacal Accutest Value + H. pylori Rapid Test Device  (Whole Blood)
K024350 Helicobacter Pylori Antibodies General Immunology 11/26/2007
JANT Pharmacal Corporation Accutest Value + Urine/Serum Pregnancy Test Device   
K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 11/16/2007
Jant Pharmacal Accustrip Strep A Value+ Test Strip  
K010582 Streptococcus, Group A Bacteriology 08/21/2007
JANT Pharmacal Corp. Accustrip Value+ hCG One Step Pregnancy Test Strip (Urine)  
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 08/17/2007
Jant Pharmacal Accutest SplitCup  (Professional Use)
K050878 Amphetamines Toxicology / TDM 08/07/2007
Jant Pharmacal Accutest SplitCup  (Professional Use)
K050878 Cannabinoids (THC) Toxicology / TDM 08/07/2007
Jant Pharmacal Accutest SplitCup  (Professional Use)
K050878 Phencyclidine (PCP) Toxicology / TDM 08/07/2007
Jant Pharmacal Accutest SplitCup  (Professional Use)
K050878 Cocaine Metabolites Toxicology / TDM 08/07/2007
Jant Pharmacal Accutest SplitCup  (Professional Use)
K050878 Opiates Toxicology / TDM 08/07/2007
Jant Pharmacal Accutest SplitCup  (Professional Use)
K050878 Methamphetamines Toxicology / TDM 08/07/2007
Jant Pharmacal Accutest SplitCup  (Professional Use)
K050878 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 08/07/2007
Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device  
K041685 Amphetamines Toxicology / TDM 05/24/2007
Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device  
K041685 Cannabinoids (THC) Toxicology / TDM 05/24/2007
Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device  
K041685 Phencyclidine (PCP) Toxicology / TDM 05/24/2007
Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device  
K041685 Cocaine Metabolites Toxicology / TDM 05/24/2007
Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device  
K041685 Opiates Toxicology / TDM 05/24/2007
Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device  
K041685 Propoxyphene Toxicology / TDM 05/24/2007
Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device  
K041685 Benzodiazepines Toxicology / TDM 05/24/2007
Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device  
K041685 Barbiturates Toxicology / TDM 05/24/2007
Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device  
K041685 Tricyclic Antidepressants Toxicology / TDM 05/24/2007
Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device  
K041685 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 05/24/2007
Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device  
K041685 Oxycodone Toxicology / TDM 05/24/2007
Jant Pharmacal Corporation Accutest TSH  (Whole Blood)
K990658 Thyroid Stimulating Hormone (TSH) Endocrinology 04/02/2007
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K993850 Urine Qualitative Dipstick Ketone Urinalysis 05/22/2006
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K993850 Urine Qualitative Dipstick Bilirubin Urinalysis 05/22/2006
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K993850 Urine Qualitative Dipstick Blood Urinalysis 05/22/2006
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 05/22/2006
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 05/22/2006
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K993850 Urine Qualitative Dipstick Nitrite Urinalysis 05/22/2006
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K993850 Urine Qualitative Dipstick pH Urinalysis 05/22/2006
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K993850 Urine Qualitative Dipstick Protein Urinalysis 05/22/2006
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K993850 Urine Qualitative Dipstick Urobilinogen Urinalysis 05/22/2006
Jant Pharmacal Accutest URS 10 Urine Reagent Strips  
K993850 Urine Qualitative Dipstick Specific Gravity Urinalysis 05/22/2006
Jant Pharmacal Accutest URS 2 Urine Reagent Strips  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 05/22/2006
Jant Pharmacal Accutest URS 2 Urine Reagent Strips  
K993850 Urine Qualitative Dipstick Protein Urinalysis 05/22/2006
Jant Pharmacal Accutest URS 4 Urine Reagent Strips  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 05/22/2006
Jant Pharmacal Accutest URS 4 Urine Reagent Strips  
K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 05/22/2006
Jant Pharmacal Accutest URS 4 Urine Reagent Strips  
K993850 Urine Qualitative Dipstick Nitrite Urinalysis 05/22/2006
Jant Pharmacal Accutest URS 4 Urine Reagent Strips  
K993850 Urine Qualitative Dipstick Protein Urinalysis 05/22/2006
Johnson & Johnson, Lifescan, Inc. One Touch Basic Blood Glucose Meter {Incline Medical, LLC Accurex Glucose Test Strip} 
K052207 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/13/2006
Johnson & Johnson, Lifescan, Inc. One Touch II Blood Glucose Meter {Incline Medical, LLC Accurex Glucose Test Strip} 
K052207 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/13/2006
Johnson & Johnson, Lifescan, Inc. One Touch Profile Blood Glucose Meter {Incline Medical, LLC Accurex Glucose Test Strip} 
K052207 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/13/2006
JANT PHARMACAL CORP CLINIPAK STREP A RAPID TEST STRIP  
K010582 Streptococcus, Group A Bacteriology 06/28/2004
JANT PHARMACAL CLINIPAK HCG ONE STEP PREGNANCY TEST DEVICE (URINE)  
K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 04/27/2004
JANT PHARMACAL CLINIPAK HCG ONE STEP PREGNANCY TEST DEVICE (URINE/SERUM)  
K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 04/27/2004
JANT PHARMACAL CLINIPAK HCG ONE STEP PREGNANCY TEST STRIP (URINE)  
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 04/27/2004
JANT PHARMACAL CLINIPAK HCG ONE STEP PREGNANCY TEST STRIP (URINE/SERUM)  
K980736 Urine hCG By Visual Color Comparison Tests Endocrinology 04/27/2004
JANT PHARMACAL CLINIPAK  
K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 01/24/2003
JANT PHARMACAL ACCUSTRIP HCG PREGNANCY TEST  
K954444 Urine hCG By Visual Color Comparison Tests Endocrinology 12/04/2001
JANT PHARMACAL H. PYLORI  
K990892 Helicobacter Pylori Antibodies General Immunology 04/03/2000
 
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