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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
Genzyme Diagnostics OSOM ImmunoDip Urinary Albumin Test  
K022538 Albumin, Urinary General Chemistry 10/26/2009
GERMAINE LABORATORIES AimStep Immunological Fecal Occult Blood Test (iFOBT)  
K063693 Fecal Occult Blood General Chemistry 09/09/2009
Guangzhou Wondfo Biotech One Step HCG Urine/Serum Test  
K072500 Urine hCG By Visual Color Comparison Tests Endocrinology 09/03/2009
Gluco Perfect LLC, Perfect Mini Blood Glucose Monitoring System  
K052818 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/30/2008
Germaine Laboratories Inc. AimStrip Urine Reagent Strips  
K051727 Urine Qualitative Dipstick Ketone Urinalysis 07/14/2008
Germaine Laboratories Inc. AimStrip Urine Reagent Strips  
K051727 Urine Qualitative Dipstick Glucose Urinalysis 07/14/2008
Germaine Laboratories Inc. AimStrip Urine Reagent Strips  
K051727 Urine Qualitative Dipstick Leukocytes Urinalysis 07/14/2008
Germaine Laboratories Inc. AimStrip Urine Reagent Strips  
K051727 Urine Qualitative Dipstick Nitrite Urinalysis 07/14/2008
Germaine Laboratories, Inc. AimStrip Urine Reagent Strips  
K051727 Urine Qualitative Dipstick Bilirubin Urinalysis 07/14/2008
Germaine Laboratories, Inc. AimStrip Urine Reagent Strips  
K051727 Urine Qualitative Dipstick Blood Urinalysis 07/14/2008
Germaine Laboratories, Inc. AimStrip Urine Reagent Strips  
K051727 Urine Qualitative Dipstick Protein Urinalysis 07/14/2008
Germaine Laboratories, Inc. AimStrip Urine Reagent Strips  
K051727 Urine Qualitative Dipstick pH Urinalysis 07/14/2008
Germaine Laboratories, Inc. AimStrip Urine Reagent Strips  
K051727 Urine Qualitative Dipstick Urobilinogen Urinalysis 07/14/2008
Germaine Laboratories, Inc. AimStrip Urine Reagent Strips  
K051727 Urine Qualitative Dipstick Specific Gravity Urinalysis 07/14/2008
Germaine Laboratories Compliance Gold iFOB (immunological fecal occult blood)Test  
K063693 Fecal Occult Blood General Chemistry 07/01/2008
Germaine Laboratories AimStrip Pregnancy  
K974368 Urine hCG By Visual Color Comparison Tests Endocrinology 06/26/2008
Gluco Perfect L.L.C., Gluco Perfect 2 Blood Glucose Monitoring System  
K062799 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/06/2007
Gluco Perfect, L.L.C. Gluco Perfect Blood Glucose Monitoring System  
K032029 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/30/2007
GlucoPlus Inc. GlucoPlus Blood Glucose Monitoring System  
K061234 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/01/2006
Genzyme Diagnostics OSOM BVBLUE Test  
K050755 Aerobic/Anaerobic Organisms - Vaginal Bacteriology 10/16/2006
Gryphus Diagnostics BVBlue  
K050755 Aerobic/Anaerobic Organisms - Vaginal Bacteriology 06/30/2006
Genzyme Sure-Vue Signature MONO Test  (Whole Blood)
K972231 Infectious Mononucleosis Antibodies (Mono) General Immunology 02/22/2006
Germaine Laboratories AimStick 10-SG  
K051727 Urine Qualitative Dipstick Chemistries Urinalysis 02/22/2006
Germaine Laboratories AimStick US-2  
K051727 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006
Germaine Laboratories AimStick US-2  
K051727 Urine Qualitative Dipstick Protein Urinalysis 02/22/2006
Germaine Laboratories AimStick US-2GK  
K051727 Urine Qualitative Dipstick Ketone Urinalysis 02/22/2006
Germaine Laboratories AimStick US-2GK  
K051727 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006
Germaine Laboratories AimStick US-2GpH  
K051727 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006
Germaine Laboratories AimStick US-2GpH  
K051727 Urine Qualitative Dipstick pH Urinalysis 02/22/2006
Germaine Laboratories AimStick US-2LN  
K051727 Urine Qualitative Dipstick Leukocytes Urinalysis 02/22/2006
Germaine Laboratories AimStick US-2LN  
K051727 Urine Qualitative Dipstick Nitrite Urinalysis 02/22/2006
Germaine Laboratories AimStick US-3  
K051727 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006
Germaine Laboratories AimStick US-3  
K051727 Urine Qualitative Dipstick pH Urinalysis 02/22/2006
Germaine Laboratories AimStick US-3  
K051727 Urine Qualitative Dipstick Protein Urinalysis 02/22/2006
Germaine Laboratories AimStick US-4  
K051727 Urine Qualitative Dipstick Blood Urinalysis 02/22/2006
Germaine Laboratories AimStick US-4  
K051727 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006
Germaine Laboratories AimStick US-4  
K051727 Urine Qualitative Dipstick pH Urinalysis 02/22/2006
Germaine Laboratories AimStick US-4  
K051727 Urine Qualitative Dipstick Protein Urinalysis 02/22/2006
Germaine Laboratories AimStick US-4OB  
K051727 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006
Germaine Laboratories AimStick US-4OB  
K051727 Urine Qualitative Dipstick Leukocytes Urinalysis 02/22/2006
Germaine Laboratories AimStick US-4OB  
K051727 Urine Qualitative Dipstick Nitrite Urinalysis 02/22/2006
Germaine Laboratories AimStick US-4OB  
K051727 Urine Qualitative Dipstick Protein Urinalysis 02/22/2006
Germaine Laboratories AimStick US-5  
K051727 Urine Qualitative Dipstick Ketone Urinalysis 02/22/2006
Germaine Laboratories AimStick US-5  
K051727 Urine Qualitative Dipstick Blood Urinalysis 02/22/2006
Germaine Laboratories AimStick US-5  
K051727 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006
Germaine Laboratories AimStick US-5  
K051727 Urine Qualitative Dipstick pH Urinalysis 02/22/2006
Germaine Laboratories AimStick US-5  
K051727 Urine Qualitative Dipstick Protein Urinalysis 02/22/2006
Germaine Laboratories AimStick US-6  
K051727 Urine Qualitative Dipstick Ketone Urinalysis 02/22/2006
Germaine Laboratories AimStick US-6  
K051727 Urine Qualitative Dipstick Bilirubin Urinalysis 02/22/2006
Germaine Laboratories AimStick US-6  
K051727 Urine Qualitative Dipstick Blood Urinalysis 02/22/2006
Germaine Laboratories AimStick US-6  
K051727 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006
Germaine Laboratories AimStick US-6  
K051727 Urine Qualitative Dipstick pH Urinalysis 02/22/2006
Germaine Laboratories AimStick US-6  
K051727 Urine Qualitative Dipstick Protein Urinalysis 02/22/2006
Germaine Laboratories AimStick US-7  
K051727 Urine Qualitative Dipstick Ketone Urinalysis 02/22/2006
Germaine Laboratories AimStick US-7  
K051727 Urine Qualitative Dipstick Bilirubin Urinalysis 02/22/2006
Germaine Laboratories AimStick US-7  
K051727 Urine Qualitative Dipstick Blood Urinalysis 02/22/2006
Germaine Laboratories AimStick US-7  
K051727 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006
Germaine Laboratories AimStick US-7  
K051727 Urine Qualitative Dipstick pH Urinalysis 02/22/2006
Germaine Laboratories AimStick US-7  
K051727 Urine Qualitative Dipstick Protein Urinalysis 02/22/2006
Germaine Laboratories AimStick US-7  
K051727 Urine Qualitative Dipstick Urobilinogen Urinalysis 02/22/2006
Germaine Laboratories AimStick US-8  
K051727 Urine Qualitative Dipstick Ketone Urinalysis 02/22/2006
Germaine Laboratories AimStick US-8  
K051727 Urine Qualitative Dipstick Bilirubin Urinalysis 02/22/2006
Germaine Laboratories AimStick US-8  
K051727 Urine Qualitative Dipstick Blood Urinalysis 02/22/2006
Germaine Laboratories AimStick US-8  
K051727 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006
Germaine Laboratories AimStick US-8  
K051727 Urine Qualitative Dipstick Nitrite Urinalysis 02/22/2006
Germaine Laboratories AimStick US-8  
K051727 Urine Qualitative Dipstick pH Urinalysis 02/22/2006
Germaine Laboratories AimStick US-8  
K051727 Urine Qualitative Dipstick Protein Urinalysis 02/22/2006
Germaine Laboratories AimStick US-8  
K051727 Urine Qualitative Dipstick Urobilinogen Urinalysis 02/22/2006
Germaine Laboratories AimStick US-9  
K051727 Urine Qualitative Dipstick Ketone Urinalysis 02/22/2006
Germaine Laboratories AimStick US-9  
K051727 Urine Qualitative Dipstick Bilirubin Urinalysis 02/22/2006
Germaine Laboratories AimStick US-9  
K051727 Urine Qualitative Dipstick Blood Urinalysis 02/22/2006
Germaine Laboratories AimStick US-9  
K051727 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006
Germaine Laboratories AimStick US-9  
K051727 Urine Qualitative Dipstick Nitrite Urinalysis 02/22/2006
Germaine Laboratories AimStick US-9  
K051727 Urine Qualitative Dipstick pH Urinalysis 02/22/2006
Germaine Laboratories AimStick US-9  
K051727 Urine Qualitative Dipstick Protein Urinalysis 02/22/2006
Germaine Laboratories AimStick US-9  
K051727 Urine Qualitative Dipstick Urobilinogen Urinalysis 02/22/2006
Germaine Laboratories AimStick US-9  
K051727 Urine Qualitative Dipstick Specific Gravity Urinalysis 02/22/2006
Germaine Laboratories AimStick US-B  
K051727 Urine Qualitative Dipstick Blood Urinalysis 02/22/2006
Germaine Laboratories AimStick US-BR  
K051727 Urine Qualitative Dipstick Bilirubin Urinalysis 02/22/2006
Germaine Laboratories AimStick US-G  
K051727 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006
Germaine Laboratories AimStick US-K  
K051727 Urine Qualitative Dipstick Ketone Urinalysis 02/22/2006
Germaine Laboratories AimStick US-L  
K051727 Urine Qualitative Dipstick Leukocytes Urinalysis 02/22/2006
Germaine Laboratories AimStick US-N  
K051727 Urine Qualitative Dipstick Nitrite Urinalysis 02/22/2006
Germaine Laboratories AimStick US-P  
K051727 Urine Qualitative Dipstick Protein Urinalysis 02/22/2006
Germaine Laboratories AimStick US-pH  
K051727 Urine Qualitative Dipstick pH Urinalysis 02/22/2006
Germaine Laboratories AimStick US-SG  
K051727 Urine Qualitative Dipstick Specific Gravity Urinalysis 02/22/2006
Germaine Laboratories AimStick US-U  
K051727 Urine Qualitative Dipstick Urobilinogen Urinalysis 02/22/2006
Good Neighbor Pharmacy Sidekick Blood Glucose Test System  (Over-The-Counter)
K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/09/2005
Genzyme Corporation OSOM hCG Combo Test  
K043385 Urine hCG By Visual Color Comparison Tests Endocrinology 04/18/2005
GENZYME OSOM TRICHOMONAS RAPID TEST  
K033864 Trichomonas Parasitology 03/16/2005
GERMAINE LABORATORIES, AIMSTEP H. PYLORI  (Whole Blood)
K024350 Helicobacter Pylori Antibodies General Immunology 12/09/2004
GENZYME OSOM ULTRA STREP A TEST  
K992658 Streptococcus, Group A Bacteriology 07/15/2004
GENOSIS FERTELL FEMALE FERTILITY TEST  
K032002 Follicle Stimulating Hormone (FSH) Endocrinology 10/21/2003
GERMAINE LABORATORIES STREP AIM TOWER  
K023766 Streptococcus, Group A Bacteriology 10/21/2003
GERMAINE LABORATORIES ACCUHOME OVULATION  
X030008 Ovulation Test (LH) By Visual Color Comparison Endocrinology 03/27/2003
GI SUPPLY, DIV. CHEK-MED SYSTEMS HP ONE  
K012411 Helicobacter Pylori Bacteriology 03/24/2003
GENZYME OSOM MONO TEST  
K972231 Infectious Mononucleosis Antibodies (Mono) General Immunology 03/06/2003
GENZYME CONTRAST II HCG URINE/SERUM  
K023544 Urine hCG By Visual Color Comparison Tests Endocrinology 02/13/2003
GERMAINE LABORATORIES STREPAIM RAPID DIPSTICK TEST  
K010582 Streptococcus, Group A Bacteriology 10/21/2002
GENZYME OSOM ULTRA STREP A TEST  (25 TEST KIT)
K992658 Streptococcus, Group A Bacteriology 07/19/2002
GERMAINE LABORATORIES AIMSTEP PREGNANCY  
K013857 Urine hCG By Visual Color Comparison Tests Endocrinology 03/03/2002
GDS TECHNOLOGY STAT-SITE M HGB TEST SYSTEM  
K020138 HGB, SINGLE ANALYTE INST. W/SELF-CONT... Hematology 02/11/2002
GOOD NEIGHBOR PHARMACY BLOOD GLUCOSE SYSTEM IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/03/2001
GENZYME SIGNIFY HCG URINE/SERUM TEST  
K964155 Urine hCG By Visual Color Comparison Tests Endocrinology 05/02/2001
GENUA MENOPAUSE MONITOR TEST  (qualitative)
K002450 Follicle Stimulating Hormone (FSH) Endocrinology 01/12/2001
GIANT EAGLE BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/13/2000
GOOD NEIGHBOR PHARMACY BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/13/2000
 
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