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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Analyte Methadone Complexity waived
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Document Analyte Analyte Specialty Effective Date
Diagnostic Test Group Clarity Multiple Drug Screen Cups  
K091588 Methadone Toxicology / TDM 04/22/2011
UCP Biosciences, Inc. UCP Drug Screening Test Cups  
K110515 Methadone Toxicology / TDM 04/22/2011
DRUG DETECTION DEVICES, LTD. Screeners AutoCup Clinical  (OTC)
K052115 Methadone Toxicology / TDM 03/24/2011
UCP Biosciences, Inc. Drug Screening Test Cards  
K091588 Methadone Toxicology / TDM 10/18/2010
UCP Biosciences, Inc. Multiple Drug Screen Cups  
K091588 Methadone Toxicology / TDM 10/18/2010
NexScreen LLC, NexScreen Cup  
K082898 Methadone Toxicology / TDM 10/04/2010
Confirm Biosciences Drugconfirm instant multi-drug test kit, Multi-Drug of Abuse Urine Test  
K063545 Methadone Toxicology / TDM 09/14/2010
Jant Pharmacal Corporation ACCUTEST Drug Test Cup  
K082898 Methadone Toxicology / TDM 09/14/2010
Amedica Biotech AmediCheck Instant Test Cup  
K082898 Methadone Toxicology / TDM 09/08/2010
American Screening Corporation Reveal Multi-Drug Testing Cups  
K091588 Methadone Toxicology / TDM 08/18/2010

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