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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
 
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Document Analyte Analyte Specialty Effective Date
UCP Biosciences, Inc. UCP Home Drug Screening Test Cards  
K130463 Buprenorphine Toxicology / TDM 05/15/2013
UCP Biosciences, Inc. UCP Home Drug Screening Test Cups  
K130463 Buprenorphine Toxicology / TDM 05/15/2013
CLIAwaived Inc. Rapid Dip Drug Test  
K082508 Buprenorphine Toxicology / TDM 05/02/2013
CLIAwaived Inc. Single Drug Dipstick Test  
K082508 Buprenorphine Toxicology / TDM 05/02/2013
Guangzhou Wondfo Biotech Co., Ltd., Wondfo Multi-Drug Urine Test Cup  (Cup format)
K130665 Buprenorphine Toxicology / TDM 04/16/2013
Guangzhou Wondfo Biotech Co., Ltd., Wondfo Multi-Drug Urine Test Panel  (Dip Card format)
K130665 Buprenorphine Toxicology / TDM 04/16/2013
Wondfo Buprenorphine Urine Test  (Dip Card format)
K130055 Buprenorphine Toxicology / TDM 02/15/2013
Wondfo Buprenorphine Urine Test  (Cup format)
K130055 Buprenorphine Toxicology / TDM 02/15/2013
Branan Medical Corporation ToxCup Drug Screen Cup  (Cassette Dip Card format)
K122633 Buprenorphine Toxicology / TDM 02/08/2013
Branan Medical Corporation Fastect II BUP Drug Screen Dipstick Test  
K082508 Buprenorphine Toxicology / TDM 08/24/2012

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