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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
Cardinal Health Leader Blood Glucose Monitoring System  
K073573 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/13/2009
CLIAwaived, Inc. Rapid Fecal Occult Blood Test  
K061065 Fecal Occult Blood General Chemistry 11/09/2009
CLIA waived inc Rapid STREP A Test  
K023270 Streptococcus, Group A Bacteriology 09/15/2009
CLIAwaived INC. Thyroid Test Rapid TSH Cassette  (Whole Blood)
K990658 Thyroid Stimulating Hormone (TSH) Endocrinology 06/03/2009
CLIAwaived Inc. Pregnancy Combo Test (Cassette)  
K984077 Urine hCG By Visual Color Comparison Tests Endocrinology 04/06/2009
CLIAwaived Inc. Pregnancy Combo Test (Dip-Strip)  
K984080 Urine hCG By Visual Color Comparison Tests Endocrinology 04/06/2009
Consult Diagnostics STREP A RAPID Dipstick {Streptococcuc, Group A} 
K010582 Streptococcus, Group A Bacteriology 04/01/2009
Card Guard Scientific Survival, Ltd. PMP4 Easy2Check Personal Wireless Blood Pressure and Blood Glucose Monitoring System  
K082521 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/22/2009
Cliawaived, Inc. CLIAWAIVED H. PYLORI WHOLE BLOOD RAPID TEST  
K024360 Helicobacter Pylori Antibodies General Immunology 01/22/2009
Conception Technologies hCG One Step Pregnancy Test Device (urine)  
K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 01/22/2009
Clia Waived.com CLIA-X Mulitple Drug Cup Test  (Professional version)
K071489 Amphetamines Toxicology / TDM 01/07/2009
Clia Waived.com CLIA-X Mulitple Drug Cup Test  (Professional version)
K071489 Cannabinoids (THC) Toxicology / TDM 01/07/2009
Clia Waived.com CLIA-X Mulitple Drug Cup Test  (Professional version)
K071489 Phencyclidine (PCP) Toxicology / TDM 01/07/2009
Clia Waived.com CLIA-X Mulitple Drug Cup Test  (Professional version)
K071489 Cocaine Metabolites Toxicology / TDM 01/07/2009
Clia Waived.com CLIA-X Mulitple Drug Cup Test  (Professional version)
K071489 Methadone Toxicology / TDM 01/07/2009
Clia Waived.com CLIA-X Mulitple Drug Cup Test  (Professional version)
K071489 Methamphetamines Toxicology / TDM 01/07/2009
Clia Waived.com CLIA-X Mulitple Drug Cup Test  (Professional version)
K071489 Benzodiazepines Toxicology / TDM 01/07/2009
Clia Waived.com CLIA-X Mulitple Drug Cup Test  (Professional version)
K071489 Barbiturates Toxicology / TDM 01/07/2009
Clia Waived.com CLIA-X Mulitple Drug Cup Test  (Professional version)
K071489 Morphine Toxicology / TDM 01/07/2009
Clia Waived.com CLIA-X Mulitple Drug Cup Test  (Professional version)
K071489 Tricyclic Antidepressants Toxicology / TDM 01/07/2009
Clia Waived.com CLIA-X Mulitple Drug Cup Test  (Professional version)
K071489 Oxycodone Toxicology / TDM 01/07/2009
CLIAwaived Inc. Pregnancy Urine Test (Dip-strip)  
K984079 Urine hCG By Visual Color Comparison Tests Endocrinology 01/05/2009
CLIAwaived, Inc. Pregnancy Urine Test (Cassette)  
K984076 Urine hCG By Visual Color Comparison Tests Endocrinology 01/05/2009
Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis  
K970250 Urine Qualitative Dipstick Ketone Urinalysis 01/05/2009
Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis  
K970250 Urine Qualitative Dipstick Bilirubin Urinalysis 01/05/2009
Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis  
K970250 Urine Qualitative Dipstick Blood Urinalysis 01/05/2009
Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis  
K970250 Urine Qualitative Dipstick Glucose Urinalysis 01/05/2009
Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis  
K970250 Urine Qualitative Dipstick Leukocytes Urinalysis 01/05/2009
Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis  
K970250 Urine Qualitative Dipstick Nitrite Urinalysis 01/05/2009
Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis  
K970250 Urine Qualitative Dipstick pH Urinalysis 01/05/2009
Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis  
K970250 Urine Qualitative Dipstick Protein Urinalysis 01/05/2009
Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis  
K970250 Urine Qualitative Dipstick Urobilinogen Urinalysis 01/05/2009
Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis  
K970250 Urine Qualitative Dipstick Specific Gravity Urinalysis 01/05/2009
Common Sense Ltd. Norma-Sense Vaginal Discharge pH Test  
X070057 pH, Urine General Chemistry 11/04/2008
Consult diagnostics Urine Analyzer  
K050801 Urine Qualitative Dipstick Ketone Urinalysis 10/17/2008
Consult diagnostics Urine Analyzer  
K050801 Urine Qualitative Dipstick Bilirubin Urinalysis 10/17/2008
Consult diagnostics Urine Analyzer  
K050801 Urine Qualitative Dipstick Blood Urinalysis 10/17/2008
Consult diagnostics Urine Analyzer  
K050801 Urine Qualitative Dipstick Glucose Urinalysis 10/17/2008
Consult diagnostics Urine Analyzer  
K050801 Urine Qualitative Dipstick Leukocytes Urinalysis 10/17/2008
Consult diagnostics Urine Analyzer  
K050801 Urine Qualitative Dipstick Nitrite Urinalysis 10/17/2008
Consult diagnostics Urine Analyzer  
K050801 Urine Qualitative Dipstick pH Urinalysis 10/17/2008
Consult diagnostics Urine Analyzer  
K050801 Urine Qualitative Dipstick Protein Urinalysis 10/17/2008
Consult diagnostics Urine Analyzer  
K050801 Urine Qualitative Dipstick Urobilinogen Urinalysis 10/17/2008
Consult diagnostics Urine Analyzer  
K050801 Urine Qualitative Dipstick Specific Gravity Urinalysis 10/17/2008
Common Sense Ltd. VA-SENSE Kit  
X070058 Vaginal pH General Chemistry 09/18/2008
Clarity MONO Mononucleosis Rapid Test  (Whole Blood)
K961024 Infectious Mononucleosis Antibodies (Mono) General Immunology 02/13/2008
Clearview COMPLETE HIV 1/2  (Fingerstick Veinipuncture, whole blood, )
BP050009 HIV-1 and HIV-2 Antibodies General Immunology 10/22/2007
Cardinal Health SP Brand Rapid Test hCG Combo  
K062361 Urine hCG By Visual Color Comparison Tests Endocrinology 07/12/2007
Clearview MONO Whole Blood  (Whole Blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 07/12/2007
Cardinal Health SP Brand Rapid Test hCG Cassette  
K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 06/28/2007
Cardinal Health SP Brand Rapid Test hCG Combo Cassette  
K062361 Urine hCG By Visual Color Comparison Tests Endocrinology 06/28/2007
Cardinal Health SP Brand Rapid Test hCG Dipstick  
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 06/28/2007
Cambridge Sensors ltd. microdot Blood Glucose Monitoring System  
K070524 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/25/2007
Cardinal Health, SP Brand Rapid Test Mono  (Whole Blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 05/31/2007
Cardinal Health SP Brand Rapid Test H. Pylori {H. Pylori} (Whole Blood)
K024350 Helicobacter Pylori Antibodies General Immunology 05/24/2007
Cardinal Health SP Brand Rapid Test Strep A Dipstick  
K010582 Streptococcus, Group A Bacteriology 05/24/2007
Cholestech LDX {Lipid Profile - ALT (GPT)} (Whole Blood)
K922612 Alanine Aminotransferase (ALT) (SGPT) General Chemistry 05/16/2007
Cholestech LDX {Lipid Profile - ALT (GPT)} (Whole Blood)
K922612 Triglyceride General Chemistry 05/16/2007
Cholestech LDX {Lipid Profile - ALT (GPT)} (Whole Blood)
K922612 HDL Cholesterol General Chemistry 05/16/2007
Cholestech LDX {Lipid Profile - ALT (GPT)} (Whole Blood)
K922612 Cholesterol General Chemistry 05/16/2007
Church & Dwight Co., Inc. FIRST RESPONSE Gold Digital Pregnancy Test  
K070054 Urine hCG By Visual Color Comparison Tests Endocrinology 05/07/2007
Clearview MONO Whole Blood  (Whole Blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 04/12/2007
Common Sense Ltd. Fem-V Test Kit  
K043109 Vaginal pH General Chemistry 01/09/2007
Chembio HIV 1/2 STAT-PAK Assay  (Fingerstick, Venipuncture Whole Blood)
BP050010 HIV Antibodies General Immunology 11/20/2006
Clarity H. pylori Rapid Test Device  (Whole Blood)
K024350 Helicobacter Pylori Antibodies General Immunology 10/20/2006
Card Guard Scientific Survival Ltd. SelfCheck Gluco Diabetes Blood Glucose Test System  
K061528 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/04/2006
CEN-MED Elite Plus hCG One Step Pregnancy Test Device (Urine/Serum)  
K981165 Urine hCG By Visual Color Comparison Tests Endocrinology 05/15/2006
Chain Drug Consortium Premier Value Sidekick Blood Glucose Testing System  
K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/09/2006
CTMI URINALYSIS REAGENT STRIPS (1-4 PARAMETERS) GLUCOSE/ PROTEIN/ NITRITE/ LEUKOCYTE/ KETONE/ PH/ BLOOD  
K993850 Urine Qualitative Dipstick Ketone Urinalysis 02/09/2006
CTMI URINALYSIS REAGENT STRIPS (1-4 PARAMETERS) GLUCOSE/ PROTEIN/ NITRITE/ LEUKOCYTE/ KETONE/ PH/ BLOOD  
K993850 Urine Qualitative Dipstick Blood Urinalysis 02/09/2006
CTMI URINALYSIS REAGENT STRIPS (1-4 PARAMETERS) GLUCOSE/ PROTEIN/ NITRITE/ LEUKOCYTE/ KETONE/ PH/ BLOOD  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 02/09/2006
CTMI URINALYSIS REAGENT STRIPS (1-4 PARAMETERS) GLUCOSE/ PROTEIN/ NITRITE/ LEUKOCYTE/ KETONE/ PH/ BLOOD  
K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 02/09/2006
CTMI URINALYSIS REAGENT STRIPS (1-4 PARAMETERS) GLUCOSE/ PROTEIN/ NITRITE/ LEUKOCYTE/ KETONE/ PH/ BLOOD  
K993850 Urine Qualitative Dipstick Nitrite Urinalysis 02/09/2006
CTMI URINALYSIS REAGENT STRIPS (1-4 PARAMETERS) GLUCOSE/ PROTEIN/ NITRITE/ LEUKOCYTE/ KETONE/ PH/ BLOOD  
K993850 Urine Qualitative Dipstick pH Urinalysis 02/09/2006
CTMI URINALYSIS REAGENT STRIPS (1-4 PARAMETERS) GLUCOSE/ PROTEIN/ NITRITE/ LEUKOCYTE/ KETONE/ PH/ BLOOD  
K993850 Urine Qualitative Dipstick Protein Urinalysis 02/09/2006
CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES  
K993850 Urine Qualitative Dipstick Ketone Urinalysis 02/09/2006
CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES  
K993850 Urine Qualitative Dipstick Bilirubin Urinalysis 02/09/2006
CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES  
K993850 Urine Qualitative Dipstick Blood Urinalysis 02/09/2006
CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 02/09/2006
CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES  
K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 02/09/2006
CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES  
K993850 Urine Qualitative Dipstick Nitrite Urinalysis 02/09/2006
CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES  
K993850 Urine Qualitative Dipstick pH Urinalysis 02/09/2006
CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES  
K993850 Urine Qualitative Dipstick Protein Urinalysis 02/09/2006
CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES  
K993850 Urine Qualitative Dipstick Urobilinogen Urinalysis 02/09/2006
CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES  
K993850 Urine Qualitative Dipstick Specific Gravity Urinalysis 02/09/2006
CAREONE Sidekick Blood Glucose Testing System  
K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/20/2005
Care Fecal Occult Blood Test  
K051806 Fecal Occult Blood General Chemistry 10/07/2005
CVS Sidekick Blood Glucose Test System  (Over-The-Counter)
K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/09/2005
Cardinal Health Leader TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
Cardinal Health Your 1st Choice For Value! TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
Chain Drug Consortium, LLC Premier Value TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
Clarity Hemosure One-Step Immunological Fecal Occult Blood Test  
K041202 Fecal Occult Blood General Chemistry 03/30/2005
CVS Pharmacy Inc. Blood Glucose Monitor, TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
Common Sense Ltd. VI-SENSE Acidity Test Kit  
K043109 Vaginal pH General Chemistry 03/07/2005
Cardinal Health SP Brand Rapid Test hCG Cassette  
K953988 Urine hCG By Visual Color Comparison Tests Endocrinology 02/04/2005
Cardinal Health SP Brand Rapid Test hCG Combo  
K992187 Urine hCG By Visual Color Comparison Tests Endocrinology 02/04/2005
Cardinal Health SP Brand Rapid Test hCG Dipstick  
K954444 Urine hCG By Visual Color Comparison Tests Endocrinology 02/04/2005
Cardinal Health SP Brand Rapid Test Strep A Dipstick  
K033855 Streptococcus, Group A Bacteriology 01/25/2005
Cardinal Health SP Brand Rapid Test H. Pylori  
K990892 Helicobacter Pylori Antibodies General Immunology 01/13/2005
CENOGENICS CHEMVIEW-10  
K042641 Urine Qualitative Dipstick Ketone Urinalysis 01/13/2005
CENOGENICS CHEMVIEW-10  
K042641 Urine Qualitative Dipstick Bilirubin Urinalysis 01/13/2005
CENOGENICS CHEMVIEW-10  
K042641 Urine Qualitative Dipstick Blood Urinalysis 01/13/2005
CENOGENICS CHEMVIEW-10  
K042641 Urine Qualitative Dipstick Glucose Urinalysis 01/13/2005
CENOGENICS CHEMVIEW-10  
K042641 Urine Qualitative Dipstick Leukocytes Urinalysis 01/13/2005
CENOGENICS CHEMVIEW-10  
K042641 Urine Qualitative Dipstick Nitrite Urinalysis 01/13/2005
CENOGENICS CHEMVIEW-10  
K042641 Urine Qualitative Dipstick pH Urinalysis 01/13/2005
CENOGENICS CHEMVIEW-10  
K042641 Urine Qualitative Dipstick Protein Urinalysis 01/13/2005
CENOGENICS CHEMVIEW-10  
K042641 Urine Qualitative Dipstick Urobilinogen Urinalysis 01/13/2005
CENOGENICS CHEMVIEW-10  
K042641 Urine Qualitative Dipstick Specific Gravity Urinalysis 01/13/2005
Cardinal Health, SP Brand Rapid Test Mono  
K973559 Infectious Mononucleosis Antibodies (Mono) General Immunology 01/10/2005
CHURCH & DWIGHT CO., INC. FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST  
K040866 Urine hCG By Visual Color Comparison Tests Endocrinology 10/22/2004
CEN-MED Elite Plus One-Step Pregnancy Test (Urine Or Serum)  
K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 10/19/2004
Clearview Ultra FOB Test  
K041297 Fecal Occult Blood General Chemistry 08/18/2004
CHASMA SCIENTIFIC, INC., CHASMA-CULT {TRI-SLIDE AND SINGLE SLIDE STOOL} 
K761232 Fecal Occult Blood General Chemistry 06/28/2004
CHASMA SCIENTIFIC, INC., CHASMA-CULT {QUICK CULT SLIDE} 
K761232 Fecal Occult Blood General Chemistry 06/28/2004
CHOLESTECH L.D.X. {Whole Blood} 
K032027 Aspartate Aminotransferase (AST) (SGOT) General Chemistry 06/18/2004
CONCEPTION TECHNOLOGIES ASSURE LH OVULATION PREDICTOR  
K924903 Ovulation Test (LH) By Visual Color Comparison Endocrinology 11/06/2003
CHDIAGNOSTICS SENOVA BLOOD GLUCOSE MONITORING SYSTEM  
K032076 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/29/2003
Cardinal Health Leader TrueTrack Smart System, Blood Glucose Monitoring System  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/22/2003
CVS Pharmacy Blood Glucose System, Truetrack Smart System  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/22/2003
CHEMICON MONOHAEM  
K901064 Fecal Occult Blood General Chemistry 05/15/2003
CENOGENICS ACCUNATE HOME PREGNANCY TEST  
K030533 Urine hCG By Visual Color Comparison Tests Endocrinology 05/01/2003
CHOLESTECH GDX A1C TEST  (Prescription Home Use)
K011933 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 07/01/2002
CONSUMER CHOICE SYSTEMS URINARY TRACT INFECTION TEST STRIP  
K990873 Urine Dipstick Or Tablet Analytes, Nonautomated Urinalysis 01/03/2002
CAMBRIDGE DIAGNOSTICS INVERNESS MEDICAL EARLY PREGNANCY TEST  
K013907 Urine hCG By Visual Color Comparison Tests Endocrinology 12/18/2001
CIDA COLOCHECK  
K911075 Fecal Occult Blood General Chemistry 09/27/2001
CHEMBIO HCG QUICKSTIX  
K011551 hCG, Urine Endocrinology 08/29/2001
CHEMBIO HCG STAT PAK II  
K011550 Urine hCG By Visual Color Comparison Tests Endocrinology 08/28/2001
CVS / PHARMACY BLOOD GLUCOSE SYSTEM IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/03/2001
CHEMBIO SURE CHECK OVULATION PREDICTOR  
K010244 Luteinizing Hormone (LH) Endocrinology 07/20/2001
CHOLESTECH L.D.X. {Whole Blood} 
K991834 Alanine Aminotransferase (ALT) (SGPT) General Chemistry 04/13/2001
CYGNUS, INC. GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER  
P990026 Glucose, Fluid (Approved By Fda For Prescription Home Use) General Chemistry 03/28/2001
 
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