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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
QUIDEL QUICKVUE DIPSTICK STREP A  (DIRECT THROAT SWAB)
K011097 Streptococcus, Group A Bacteriology 09/25/2008
Quidel QuickVue In-Line Strep A  (direct from throat swab)
K934484 Streptococcus, Group A Bacteriology 09/25/2008
Quidel QuickVue Influenza A+B Test  
K053146 Influenza A/B Virology 09/25/2008
Quidel QuickVue Influenza Test  
K991633 Influenza A/B Virology 09/25/2008
Quidel QuickVue RSV Test  
K070747 Respiratory Syncytial Virus Virology 09/25/2008
Quidel QuickVue RSV Test  
K061008 Respiratory Syncytial Virus Virology 09/25/2008
Qualigen, Inc. FastChek TSH  (Whole Blood)
K990658 Thyroid Stimulating Hormone (TSH) Endocrinology 02/29/2008
Quidel QuickVue RSV Test  
K070747 Respiratory Syncytial Virus Virology 02/25/2008
Quidel QuickVue RSV Test  
K061008 Respiratory Syncytial Virus Virology 02/25/2008
Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup  (Professional Use)
K050878 Amphetamines Toxicology / TDM 12/13/2007
Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup  (Professional Use)
K050878 Cannabinoids (THC) Toxicology / TDM 12/13/2007
Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup  (Professional Use)
K050878 Phencyclidine (PCP) Toxicology / TDM 12/13/2007
Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup  (Professional Use)
K050878 Cocaine Metabolites Toxicology / TDM 12/13/2007
Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup  (Professional Use)
K050878 Opiates Toxicology / TDM 12/13/2007
Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup  (Professional Use)
K050878 Methamphetamines Toxicology / TDM 12/13/2007
Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup  (Professional Use)
K050878 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 12/13/2007
QuantRx Biomedical QuantRx Female Fertility Test  
K070484 Follicle Stimulating Hormone (FSH) Endocrinology 10/29/2007
QuickVue iFOB Test (Immunochemical Fecal Occult Blood)  (cassette)
K021423 Fecal Occult Blood General Chemistry 11/09/2005
QUIDEL QUICKVUE ADVANCE PH AND AMINES TEST  
K040008 Vaginal pH General Chemistry 05/03/2004
QUIDEL QUICKVUE ADVANCE PH AND AMINES TEST  
K040008 Amines General Chemistry 05/03/2004
Quidel QuickVue Influenza A+B Test  
K031899 Influenza A Virology 02/06/2004
Quidel QuickVue Influenza A+B Test  
K031899 Influenza B Virology 02/06/2004
QUIDEL QUICKVUE+ ONE-STEP HCG COMBO  
K973858 Urine hCG By Visual Color Comparison Tests Endocrinology 09/08/2003
Quidel QuickVue In-Line Strep A  
K934484 Streptococcus, Group A Bacteriology 07/08/2002
QUIDEL OVUQUICK ONE-STEP OVULATION PREDICTOR  
K953063 Ovulation Test (LH) By Visual Color Comparison Endocrinology 06/13/2002
QUIDEL QUICKVUE ADVANCE PH AND AMINES TEST  
K962718 Vaginal pH General Chemistry 06/13/2002
QUIDEL QUICKVUE ADVANCE PH AND AMINES TEST  
K962718 Amines General Chemistry 06/13/2002
QUIDEL QUICKVUE ONE-STEP HCG-COMBO  
K020801 Urine hCG By Visual Color Comparison Tests Endocrinology 05/17/2002
QUIDEL QUICKVUE ONE-STEP HCG-URINE  
K020799 Urine hCG By Visual Color Comparison Tests Endocrinology 05/17/2002
QUIDEL QUICKVUE URINCHEK 10+SG  
K861255 Urine Dipstick Or Tablet Analytes, Nonautomated Urinalysis 12/17/2001
QUIDEL QUICKVUE URINCHEK 10+SG  
K861255 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 12/17/2001
QUIDEL QUICKVUE+ INFECTIOUS MONONUCLEOSIS  (Whole Blood)
K902510 Infectious Mononucleosis Antibodies (Mono) General Immunology 12/17/2001
QUIDEL QUICKVUE URINCHEK 2+  
K861255 Urine Qualitative Dipstick Glucose Urinalysis 12/04/2001
QUIDEL QUICKVUE URINCHEK 2+  
K861255 Urine Qualitative Dipstick Protein Urinalysis 12/04/2001
QUIDEL QUICKVUE URINCHEK 2+  
K861255 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 12/04/2001
QUIDEL QUICKVUE URINCHEK 6+  
K861255 Urine Qualitative Dipstick Blood Urinalysis 12/04/2001
QUIDEL QUICKVUE URINCHEK 6+  
K861255 Urine Qualitative Dipstick Glucose Urinalysis 12/04/2001
QUIDEL QUICKVUE URINCHEK 6+  
K861255 Urine Qualitative Dipstick Leukocytes Urinalysis 12/04/2001
QUIDEL QUICKVUE URINCHEK 6+  
K861255 Urine Qualitative Dipstick pH Urinalysis 12/04/2001
QUIDEL QUICKVUE URINCHEK 6+  
K861255 Urine Qualitative Dipstick Protein Urinalysis 12/04/2001
QUIDEL QUICKVUE URINCHEK 6+  
K861255 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 12/04/2001
QUIDEL QUICKVUE URINCHEK 8+  
K861255 Urine Qualitative Dipstick Ketone Urinalysis 12/04/2001
QUIDEL QUICKVUE URINCHEK 8+  
K861255 Urine Qualitative Dipstick Blood Urinalysis 12/04/2001
QUIDEL QUICKVUE URINCHEK 8+  
K861255 Urine Qualitative Dipstick Glucose Urinalysis 12/04/2001
QUIDEL QUICKVUE URINCHEK 8+  
K861255 Urine Qualitative Dipstick Nitrite Urinalysis 12/04/2001
QUIDEL QUICKVUE URINCHEK 8+  
K861255 Urine Qualitative Dipstick pH Urinalysis 12/04/2001
QUIDEL QUICKVUE URINCHEK 8+  
K861255 Urine Qualitative Dipstick Protein Urinalysis 12/04/2001
QUIDEL QUICKVUE URINCHEK 8+  
K861255 Urine Qualitative Dipstick Urobilinogen Urinalysis 12/04/2001
QUIDEL QUICKVUE URINCHEK 8+  
K861255 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 12/04/2001
QUIDEL QUICKVUE DIPSTICK STREP A  (DIRECT THROAT SWAB)
K011097 Streptococcus, Group A Bacteriology 07/26/2001
Quidel Quickvue Influenza A/B  
K991633 Influenza A/B Virology 10/04/2000
QUIDEL QUICKVUE URINE CHECK  
K861255 Urine Dipstick Or Tablet Analytes, Nonautomated Urinalysis 05/23/2000
 
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