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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Analyte Opiates Complexity waived Effective Date To 07/22/2014
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Document Parent Analyte Analyte Specialty Effective Date
Cliawaived Inc. Instant Drug Test Cup  
K130665   Opiates Toxicology / TDM 05/29/2013
Cliawaived Inc. Drug of Abuse Card  
K130665   Opiates Toxicology / TDM 05/29/2013
US Diagnostics Inc. UScreen Drugs of Abuse Card  
K130665   Opiates Toxicology / TDM 05/29/2013
US Diagnostics Inc. Uscreen Drug of Abuse Cup  
K130665   Opiates Toxicology / TDM 05/29/2013
Alere iScreen DX Single Dip Card  
K022355   Opiates Toxicology / TDM 05/29/2013
Alere Toxicology Services, Inc. Tox Screen Drugs of Abuse Test Cup  (Professional Use)
K050878   Opiates Toxicology / TDM 05/17/2013
SDBiotek Corporation ForSure Buprenorphine Drug CupTest  
K122064   Opiates Toxicology / TDM 05/09/2013
Nobel Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Cup  
K121166   Opiates Toxicology / TDM 03/15/2013
American Screening Corporation Discover Drug Test Cards  
K123863   Opiates Toxicology / TDM 02/27/2013
American Screening Corporation Discover Multi-Panel Drug Test Cups  
K123863   Opiates Toxicology / TDM 02/27/2013

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