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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
UCP Biosciences, Inc. UCP Home Drug Screening Test Cards  
K091588 Amphetamines Toxicology / TDM 09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cards  
K091588 Cannabinoids (THC) Toxicology / TDM 09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cards  
K091588 Phencyclidine (PCP) Toxicology / TDM 09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cards  
K091588 Cocaine Metabolites Toxicology / TDM 09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cards  
K091588 Opiates Toxicology / TDM 09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cards  
K091588 Methadone Toxicology / TDM 09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cards  
K091588 Methamphetamines Toxicology / TDM 09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cards  
K091588 Benzodiazepines Toxicology / TDM 09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cards  
K091588 Barbiturates Toxicology / TDM 09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cards  
K091588 Morphine Toxicology / TDM 09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cards  
K091588 Tricyclic Antidepressants Toxicology / TDM 09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cards  
K091588 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cards  
K091588 Oxycodone Toxicology / TDM 09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cups  
K091588 Amphetamines Toxicology / TDM 09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cups  
K091588 Cannabinoids (THC) Toxicology / TDM 09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cups  
K091588 Phencyclidine (PCP) Toxicology / TDM 09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cups  
K091588 Cocaine Metabolites Toxicology / TDM 09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cups  
K091588 Opiates Toxicology / TDM 09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cups  
K091588 Methadone Toxicology / TDM 09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cups  
K091588 Methamphetamines Toxicology / TDM 09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cups  
K091588 Benzodiazepines Toxicology / TDM 09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cups  
K091588 Barbiturates Toxicology / TDM 09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cups  
K091588 Morphine Toxicology / TDM 09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cups  
K091588 Tricyclic Antidepressants Toxicology / TDM 09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cups  
K091588 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cups  
K091588 Oxycodone Toxicology / TDM 09/30/2009
U.S. Diagnostics Inc. ACURA Blood Glucose Monitoring System  
K083468 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/16/2009
US Diagnostics, Inc. Infinity Blood Glucose Monitoring System  
K082201 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/25/2009
US Diagnostics, Inc. Maxima Blood Glucose Monitoring System  
K051651 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/20/2007
US Diagnostics, Inc. EASYGLUCO Glucose Monitoring System  
K061431 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/18/2007
UltraCrit  
BK050056 Hematocrit Hematology 08/31/2006
US Diagnostics, Inc. G4 Blood Glucose Monitoring System  
K051651 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/19/2006
US Diagnostics, Inc. EASYGLUCO Blood Monitoring System  
K043512 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/21/2005
US Diagnostics, Inc. Freedom Blood Glucose Monitoring System  
K043543 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/20/2005
UNIPATH DIAGNOSTICS FACT PLUS ONE-STEP PREGNANCY TEST  
K042280 Urine hCG By Visual Color Comparison Tests Endocrinology 09/14/2004
UNIPATH DIAGNOSTICS CLEARBLUE EASY EASY READ PREGNANCY TEST  
K041404 Urine hCG By Visual Color Comparison Tests Endocrinology 06/28/2004
UNIPATH DIAGNOSTICS CLEARBLUE EASY DIGITAL OVULATION TEST  
X040028 Ovulation Test (LH) By Visual Color Comparison Endocrinology 03/23/2004
UNIPATH DIAGNOSTICS CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST  
K040341 Urine hCG By Visual Color Comparison Tests Endocrinology 03/11/2004
UNOTECH DIAGNOSTICS ACCUSTRIP HCG-COMBO MODEL, HCG-005  
K032987 hCG, Urine Endocrinology 12/09/2003
UNOTECH DIAGNOSTICS ACCUTEST HCG-COMBO MODEL,HCG-004  
K032987 hCG, Urine Endocrinology 12/09/2003
UNIPATH EPT CERTAINTY PREGNANCY TEST  
K032939 Urine hCG By Visual Color Comparison Tests Endocrinology 10/15/2003
UNIPATH CLEARBLUE EASY OVULATION TEST  
K981271 Ovulation Test (LH) By Visual Color Comparison Endocrinology 07/31/2003
UNIPATH CLEARBLUE EASY DIGITAL PREGNANCY TEST {OTC} 
K030659 Urine hCG By Visual Color Comparison Tests Endocrinology 05/14/2003
UNIPATH CLEARBLUE EASY EARLY RESULT PREGNANCY TEST  
K023699 Urine hCG By Visual Color Comparison Tests Endocrinology 11/27/2002
UNIPATH CLEARPLAN EASY OVULATION TEST  
K013874 Ovulation Test (LH) By Visual Color Comparison Endocrinology 03/14/2002
UNIPATH CLEARBLUE EASY EARLY RESULT PREGNANCY TEST  
K013372 Urine hCG By Visual Color Comparison Tests Endocrinology 11/06/2001
UNIPATH CLEARPLAN EASY FERTILITY MONITOR  
K981207 Ovulation Test (LH) By Visual Color Comparison Endocrinology 07/17/2000
UNIPATH CLEARPLAN EASY FERTILITY MONITOR  
K981207 Estrone-3 Glucuronide Endocrinology 07/17/2000
 
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