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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Analyte Buprenorphine Complexity waived Effective Date To 07/31/2014
 
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Document Parent Analyte Analyte Specialty Effective Date
Biotech Screening., LLC., Biotech Screening Corrections Cup  (Cup format)
CR140243 K130665 Buprenorphine Toxicology / TDM 07/07/2014
Ekla Corporation NOVAPLUS Buprenorphine Drug Test Cup  
CR140222 K122064 Buprenorphine Toxicology / TDM 06/27/2014
American Screening Corporation Discover Multi-Drug Key Cups  
CR140084 K132812 Buprenorphine Toxicology / TDM 05/02/2014
PTox Drug Screen Cup  (Cassette Dip Card format)
K122633   Buprenorphine Toxicology / TDM 04/11/2014
UCP Biosciences, Inc. UCP Multi-Drug Test Key Cups  
K132812   Buprenorphine Toxicology / TDM 03/13/2014
Wondfo Buprenorphine Multi-drug Urine Test  (Cup format)
K133968   Buprenorphine Toxicology / TDM 03/07/2014
Wondfo Buprenorphine Multi-drug Urine Test  (Dip Card format)
K133968   Buprenorphine Toxicology / TDM 03/07/2014
Ultimate Analysis Cup Inc. UA Cups Test Cards  
K130463   Buprenorphine Toxicology / TDM 02/21/2014
Ultimate Analysis Cup Inc. UA Cups  
K130463   Buprenorphine Toxicology / TDM 02/21/2014
Micro Distributing II, LTD STATCup3 One Step Drug Test Cup  
K130665   Buprenorphine Toxicology / TDM 12/05/2013

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