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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
Excel Medical Group Bio View hCG Pregnancy Serum/Urine Cassette and Dipstick Tests  
K071030 Urine hCG By Visual Color Comparison Tests Endocrinology 09/09/2009
EPS Bio Technology Corp. EasyPlus mini R13N Self-Monitoring Blood Glucose System  
K091481 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/01/2009
Early Detect Inc., EarlyDETECT Pro hCG Urine pregnancy test card  
K020968 Urine hCG By Visual Color Comparison Tests Endocrinology 06/12/2009
Early Detect Inc., EarlyDETECT Pro hCG Urine pregnancy test strip  
K020968 Urine hCG By Visual Color Comparison Tests Endocrinology 06/12/2009
EarlyDETECT H. PYLORI WHOLE BLOOD RAPID TEST  
K024360 Helicobacter Pylori Bacteriology 05/21/2009
EarlyDetect Pro Influenza A Test  
K041441 Influenza A Virology 03/10/2009
EarlyDetect Pro Influenza B Test  
K041439 Influenza B Virology 03/10/2009
EPS Bio Technology Corp. EasyPlus mini R2N Self-Monitoring Blood Glucose Test System  
K081796 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/27/2009
EPS Bio Technology EasyMax N Self Monitoring Blood Glucose Test System  
K083099 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/27/2009
Entra Health Systems, Ltd., MyGlucoHealth Glucose Monitoring System  
K081703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/09/2009
EPS Bio Technology EasyPlus mini EasyMax self monitoring blood glucose system  
K082121 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/18/2008
EPS Bio Technology EasyPlus mini Self Monitoring Blood Glucose System  
K070053 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/06/2007
Exir Pharmaceutical Maximed Exichek TD-4224 Blood Glucose Monitoring System  
K070239 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/27/2007
eScreen, Inc. mCheck Multi-Line Screen Test Device  
K050050 Amphetamines Toxicology / TDM 06/28/2007
eScreen, Inc. mCheck Multi-Line Screen Test Device  
K050050 Cannabinoids (THC) Toxicology / TDM 06/28/2007
eScreen, Inc. mCheck Multi-Line Screen Test Device  
K050050 Phencyclidine (PCP) Toxicology / TDM 06/28/2007
eScreen, Inc. mCheck Multi-Line Screen Test Device  
K050050 Cocaine Metabolites Toxicology / TDM 06/28/2007
eScreen, Inc. mCheck Multi-Line Screen Test Device  
K050050 Opiates Toxicology / TDM 06/28/2007
eScreen, Inc. mCheck Multi-Line Screen Test Device  
K050050 Methamphetamines Toxicology / TDM 06/28/2007
EUKARE Blood Glucose Monitoring System  
K062892 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/26/2007
EPS Bio Technology Easy Plus Blood Glucose Monitoring System  
K061992 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/22/2006
ESA Biosciences LeadCare II Blood Lead Testing System  (Whole Blood)
K052549 Blood Lead Toxicology / TDM 09/18/2006
ENTERIX INSURE II FECAL IMMUNOCHEMICAL TEST  
K060930 Fecal Occult Blood General Chemistry 08/03/2006
Eckerd Pharmacy Sidekick Blood Glucose Test System  
K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/22/2005
EPS Bio Technology Easy Pain Supreme Blood Glucose Monitoring System  
K043245 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/27/2005
Eckerd Drug Company TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
Eumed Biotechnology Co. Eusure Blood Glucose Monitoring System  
K040678 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/18/2004
EKF DIAGNOSTIC HEMO_CONTROL MEASUREMENT AND HEMO_CONTROL MICROCUVETTES  
K031898 Hemoglobin Hematology 11/03/2003
ENTERIX INSURE FECAL IMMUNOCHEMICAL TEST  
K002457 Fecal Occult Blood General Chemistry 10/16/2003
EMBRYOTECH LABORATORIES FERTILMARQ HOME DIAGNOSTIC SCREENING TEST FOR MALE INFERTILITY  
K011679 Semen Hematology 08/15/2001
ENTERIX !NSURE FECAL OCCULT BLOOD TEST  
K002457 Fecal Occult Blood General Chemistry 01/31/2001
EXPRESS MED BLOOD GLYCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/13/2000
 
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