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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
Major Biosystem Corp. AP-1000 Blood Glucose Monitoring System  
K090389 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/14/2009
MEC Dynamics Avie A1c Test System  
K081269 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 04/01/2009
MACHEREY-NAGEL Medi-Test Glucose  
K991927 Urine Qualitative Dipstick Glucose Urinalysis 03/16/2009
Mossman Associates, Inc. NicCheck I Test Strips  
K963733 Nicotine And/Or Metabolites Toxicology / TDM 11/04/2008
Moore Medical The Supply Experts Strep A Test - Cassette {Strep A} 
K023766 Streptococcus, Group A Bacteriology 03/19/2008
Macherey-Nagel URYXXON Relax  
K061742 Urine Qualitative Dipstick Ketone Urinalysis 11/08/2007
Macherey-Nagel URYXXON Relax  
K061742 Urine Qualitative Dipstick Bilirubin Urinalysis 11/08/2007
Macherey-Nagel URYXXON Relax  
K061742 Urine Qualitative Dipstick Blood Urinalysis 11/08/2007
Macherey-Nagel URYXXON Relax  
K061742 Urine Qualitative Dipstick Glucose Urinalysis 11/08/2007
Macherey-Nagel URYXXON Relax  
K061742 Urine Qualitative Dipstick Leukocytes Urinalysis 11/08/2007
Macherey-Nagel URYXXON Relax  
K061742 Urine Qualitative Dipstick pH Urinalysis 11/08/2007
Macherey-Nagel URYXXON Relax  
K061742 Urine Qualitative Dipstick Protein Urinalysis 11/08/2007
Macherey-Nagel URYXXON Relax  
K061742 Urine Qualitative Dipstick Specific Gravity Urinalysis 11/08/2007
Macherey-Nagel URYXXON Relax  
K061742 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 11/08/2007
Macherey-Nagel URYXXON Relax   
K061742 Urine Qualitative Dipstick Nitrite Urinalysis 11/08/2007
Macherey-Nagel URYXXON Relax   
K061742 Urine Qualitative Dipstick Urobilinogen Urinalysis 11/08/2007
Moore Medical The Supply Experts hCG Urine -Dipstick  
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 09/21/2007
Moore Medical The Supply Experts hCG Urine-Cassette  
K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 09/21/2007
Moore Medical The Supply Experts hCG Serum/Urine Test-Cassette  
K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 08/24/2007
Moore Medical The Supply Experts Strep A Rapid Test - Dipstick  
K010582 Streptococcus, Group A Bacteriology 08/14/2007
McKesson Medi-Lab Performance H. pylori Test  (Whole Blood)
K024350 Helicobacter Pylori Antibodies General Immunology 06/11/2007
McKesson Medi-Lab Performance Strep A Test - Twist  
K023766 Streptococcus, Group A Bacteriology 05/10/2007
Medi-Lab Performance Infectious Mononucleosis Test  (Whole Blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 04/12/2007
Mckesson Medi-Lab Strep A Test - Dipstick  
K010582 Streptococcus, Group A Bacteriology 03/28/2007
McKesson Medical-Surgical Medi-Lab Performance hCG Combo Test-Cassette  
K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 03/28/2007
McKesson Medical-Surgical, Medi-Lab Performance hCG Urine Test - Cassette  
K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 03/07/2007
McKesson Medical-Surgical, Medi-Lab Performance hCG Urine Test - Dipstick  
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 03/07/2007
Mizuho USA Multi-Use Electronic Pregnancy Test  
K060825 Urine hCG By Visual Color Comparison Tests Endocrinology 06/20/2006
Meridian Bioscience Immunocard STAT! HpSA  (Stool)
K032222 Helicobacter Pylori Bacteriology 05/31/2006
MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)  
K993850 Urine Qualitative Dipstick Ketone Urinalysis 04/19/2006
MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)  
K993850 Urine Qualitative Dipstick Bilirubin Urinalysis 04/19/2006
MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)  
K993850 Urine Qualitative Dipstick Blood Urinalysis 04/19/2006
MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 04/19/2006
MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)  
K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 04/19/2006
MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)  
K993850 Urine Qualitative Dipstick Nitrite Urinalysis 04/19/2006
MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)  
K993850 Urine Qualitative Dipstick pH Urinalysis 04/19/2006
MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)  
K993850 Urine Qualitative Dipstick Protein Urinalysis 04/19/2006
MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)  
K993850 Urine Qualitative Dipstick Urobilinogen Urinalysis 04/19/2006
MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)  
K993850 Urine Qualitative Dipstick Specific Gravity Urinalysis 04/19/2006
MACHEREY-NAGEL Medi-Test Combi 10 SGL  
K991927 Urine Qualitative Dipstick Ketone Urinalysis 03/13/2006
MACHEREY-NAGEL Medi-Test Combi 10 SGL  
K991927 Urine Qualitative Dipstick Bilirubin Urinalysis 03/13/2006
MACHEREY-NAGEL Medi-Test Combi 10 SGL  
K991927 Urine Qualitative Dipstick Blood Urinalysis 03/13/2006
MACHEREY-NAGEL Medi-Test Combi 10 SGL  
K991927 Urine Qualitative Dipstick Glucose Urinalysis 03/13/2006
MACHEREY-NAGEL Medi-Test Combi 10 SGL  
K991927 Urine Qualitative Dipstick Leukocytes Urinalysis 03/13/2006
MACHEREY-NAGEL Medi-Test Combi 10 SGL  
K991927 Urine Qualitative Dipstick Nitrite Urinalysis 03/13/2006
MACHEREY-NAGEL Medi-Test Combi 10 SGL  
K991927 Urine Qualitative Dipstick pH Urinalysis 03/13/2006
MACHEREY-NAGEL Medi-Test Combi 10 SGL  
K991927 Urine Qualitative Dipstick Protein Urinalysis 03/13/2006
MACHEREY-NAGEL Medi-Test Combi 10 SGL  
K991927 Urine Qualitative Dipstick Urobilinogen Urinalysis 03/13/2006
MACHEREY-NAGEL Medi-Test Combi 10 SGL  
K991927 Urine Qualitative Dipstick Specific Gravity Urinalysis 03/13/2006
McKesson SunMark Sidekick Blood Glucose Testing System  
K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/09/2006
Meridian Bioscience ImmunoCard STAT! RSV PLUS  
K041445 Respiratory Syncytial Virus Virology 10/20/2005
McKesson SunMark Performance Plus Sidekick Blood Glucose Test System  
K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/22/2005
Medicine Shoppe Sidekick Blood Glucose Test System  
K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/22/2005
Meijer Sidekick Blood Glucose Test System  
K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/22/2005
McKesson Corporation Medi-Lab Performance hCG Urine - Cassette  
K953988 Urine hCG By Visual Color Comparison Tests Endocrinology 08/01/2005
Mizuho USA Proof Positive  
K000844 Urine hCG By Visual Color Comparison Tests Endocrinology 08/01/2005
Metrika INViEW MULTI-TEST A1C MONITOR  (For OTC use)
K051321 Glycated Hemoglobin, Total General Chemistry 06/15/2005
Metrika INViEW MULTI-TEST A1C MONITOR  (For professional use)
K051321 Glycated Hemoglobin, Total General Chemistry 06/15/2005
McKesson Corporation Medi-Lab Performance hCG Combo - Cassette  
K992187 Urine hCG By Visual Color Comparison Tests Endocrinology 06/03/2005
McKesson Corporation Medi-Lab Performance hCG Urine - Dipstick  
K954444 Urine hCG By Visual Color Comparison Tests Endocrinology 06/03/2005
Mizuho USA Proof Positive Electronic Pregnancy Test  
K043231 Urine hCG By Visual Color Comparison Tests Endocrinology 04/26/2005
McKesson Corporation SunMark Performance Plus Blood Glucose Monitoring System, TrueTrack Smart System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
McKesson Sunmark TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
Medicine Shoppe International TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
Meijer Distribution Inc. Blood Glucose Monitor, TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
McKesson Medi-Lab Performance Infectious Mononucleosis Test  
K973559 Infectious Mononucleosis Antibodies (Mono) General Immunology 03/16/2005
Matrix Distributors, Inc. NexGen Blood Glucose Monitoring System  
K031388 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/09/2005
MCKESSON MEDI-LAB PERFORMANCE STREP A TEST DIPSTICK  
K033855 Streptococcus, Group A Bacteriology 03/08/2005
Matrix Distributors, Inc. NexGen Blood Glucose Monitoring System  
K020232 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/20/2004
MEDISENSE PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM  
K040628 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/26/2004
MAINLINE MAXIE HCG URINE PREGNANCY TEST  
K031445 Urine hCG By Visual Color Comparison Tests Endocrinology 07/02/2003
MEDLINE INDUSTRIES EVENCARE BLOOD GLUCOSE MONITORING SYSTEM  
K031843 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/02/2003
MEDLINE INDUSTRIES EVENCARE BLOOD GLUCOSE MONITORING SYSTEM  
K011240 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/23/2003
Metrika A1cNow For Home Use  
K022661 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 11/19/2002
MEDISENSE OPTIUM EASY BLOOD GLUCOSE TESTING SYSTEM  
K022182 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/06/2002
MEDISENSE PRECISION EASY BLOOD GLUCOSE TESTING SYSTEM  
K022182 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/06/2002
MATRITECH BLADDERCHEK  (Prescription Home Use)
K021231 Bladder Tumor Associated Antigen General Immunology 08/12/2002
MATRITECH BLADDERCHEK  (Professional Use)
K021231 Bladder Tumor Associated Antigen General Immunology 08/12/2002
MERIDIAN BIOSCIENCE IMMUNOCARD STAT! H. PYLORI WHOLE BLOOD TEST  
K990892 Helicobacter Pylori Antibodies General Immunology 08/09/2002
METRIKA A1CNOW FOR PRESCRIPTION HOME USE  
K020234 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 03/08/2002
Metrika DRX Professional Use Hemoglobin A1c Test  
K020235 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 03/08/2002
MEDISENSE SOF-TACT DIABETES MANAGEMENT SYSTEM  
K012975 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/17/2001
MEDICAL INSTRUMENTS PRONTO DRY  
K002451 Helicobacter Pylori Bacteriology 08/30/2001
METRIKA A1C NOW  
K000887 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 08/17/2001
MEDTEK DIAGNOSTICS INSTACCULT  
K002930 Fecal Occult Blood General Chemistry 01/30/2001
MEDIC BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/13/2000
METRIKA DRX HBA1C PRESCRIPTION HOME USE  
K000885 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 11/30/2000
MEIJER BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/29/2000
Metrika DRX Professional Use Hemoglobin A1c Test  
K000887 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 11/27/2000
MEDISENSE SOF-TACT DIABETES MANAGEMENT SYSTEM  
K001993 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/20/2000
MIZUHO USA ABSOLUTE HCG PREGNANCY TEST  
K000844 Urine hCG By Visual Color Comparison Tests Endocrinology 06/15/2000
MACHEREY-NAGEL MEDI TEST COMBI 11  
K991927 Urine Qualitative Dipstick Ketone Urinalysis 04/03/2000
MACHEREY-NAGEL MEDI TEST COMBI 11  
K991927 Urine Dipstick Or Tablet Analytes, Nonautomated Urinalysis 04/03/2000
MACHEREY-NAGEL MEDI TEST COMBI 11  
K991927 Urine Qualitative Dipstick Bilirubin Urinalysis 04/03/2000
MACHEREY-NAGEL MEDI TEST COMBI 11  
K991927 Urine Qualitative Dipstick Blood Urinalysis 04/03/2000
MACHEREY-NAGEL MEDI TEST COMBI 11  
K991927 Urine Qualitative Dipstick Glucose Urinalysis 04/03/2000
MACHEREY-NAGEL MEDI TEST COMBI 11  
K991927 Urine Qualitative Dipstick Leukocytes Urinalysis 04/03/2000
MACHEREY-NAGEL MEDI TEST COMBI 11  
K991927 Urine Qualitative Dipstick Nitrite Urinalysis 04/03/2000
MACHEREY-NAGEL MEDI TEST COMBI 11  
K991927 Urine Qualitative Dipstick pH Urinalysis 04/03/2000
MACHEREY-NAGEL MEDI TEST COMBI 11  
K991927 Urine Qualitative Dipstick Protein Urinalysis 04/03/2000
MACHEREY-NAGEL MEDI TEST COMBI 11  
K991927 Urine Qualitative Dipstick Urobilinogen Urinalysis 04/03/2000
MACHEREY-NAGEL MEDI TEST COMBI 11  
K991927 Urine Qualitative Dipstick Specific Gravity Urinalysis 04/03/2000
MACHEREY-NAGEL MEDI TEST COMBI 11  
K991927 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 04/03/2000
 
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