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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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1 to 10 of 166 Results
Analyte Opiates Complexity waived Effective Date To 04/21/2014
 
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Document Parent Analyte Analyte Specialty Effective Date
Jant Pharmacal Corp. Accutest (MDMA and OPI) Drug Test Cup  {Urine} (Cup format)
K130275   Opiates Toxicology / TDM 03/20/2014
UCP Biosciences, Inc. UCP Multi-Drug Test Key Cups  
K132812   Opiates Toxicology / TDM 03/13/2014
Revolution Diagnostics Corp. AccuSeal Pro Instant Test Cup  {Urine} (Cup format)
K130275   Opiates Toxicology / TDM 03/07/2014
Ultimate Analysis Cup Inc. UA Cups Test Cards  
K130463   Opiates Toxicology / TDM 02/21/2014
Ultimate Analysis Cup Inc. UA Cups  
K130463   Opiates Toxicology / TDM 02/21/2014
Micro Distributing II, LTD STATCup3 One Step Drug Test Cup  
K130665   Opiates Toxicology / TDM 12/05/2013
Micro Distributing II, LTD STATDIP One Step Multi-Drug Urine Test Panel  
K130665   Opiates Toxicology / TDM 12/05/2013
BTNX, Inc. Rapid Response Multi-Drug Urine Test Cup  
K130665   Opiates Toxicology / TDM 12/05/2013
BTNX, Inc. Rapid Response Multi-Drug Urine Test Panel  
K130665   Opiates Toxicology / TDM 12/05/2013
Noble Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Cup  (Cup format)
K130665   Opiates Toxicology / TDM 11/19/2013

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