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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Analyte Amphetamines Complexity waived
 
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Document Analyte Analyte Specialty Effective Date
Alere Toxicology Services, Inc. Tox Screen Drugs of Abuse Test Cup  (Professional Use)
K050878 Amphetamines Toxicology / TDM 05/17/2013
American Screening Corporation Discover Drug Test Cards  
K123863 Amphetamines Toxicology / TDM 02/27/2013
American Screening Corporation Discover Multi-Panel Drug Test Cups  
K123863 Amphetamines Toxicology / TDM 02/27/2013
Branan Medical Corporation ToxCup Drug Screen Cup  (Cassette Dip Card format)
K122633 Amphetamines Toxicology / TDM 02/08/2013
CLIAwaived, Inc. Rapid Drug Test Cup  
K052115 Amphetamines Toxicology / TDM 02/08/2013
Clinical Reference Laboratory, Inc. Intelligent Transport Cup  
K052115 Amphetamines Toxicology / TDM 02/08/2013
Noble Medical Inc. NOBLE 1 Step Cup  
K052115 Amphetamines Toxicology / TDM 02/08/2013
Premier Integrity Solutions P/Tox Drug Screen Cup  
K052115 Amphetamines Toxicology / TDM 02/08/2013
US Diagnostics ProScreen Drugs of Abuse Cup  
K052115 Amphetamines Toxicology / TDM 02/08/2013
Micro Distributing II, Ltd STAT CUP One Step Drug TEST Cup  (Cup format)
K122904 Amphetamines Toxicology / TDM 02/05/2013

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