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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Analyte Amines Complexity waived
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Document Analyte Analyte Specialty Effective Date
American Screening Corporation, Inc., Multi-Drug Testing Cups  
K110515 Amphetamines Toxicology / TDM 01/04/2013
American Screening Corporation, Inc., Multi-Drug Testing Cups  
K110515 Methamphetamines Toxicology / TDM 01/04/2013
Clinical Reference Laboratory, Inc. Intelligent Transport Cup  (OTC)
K052115 Amphetamines Toxicology / TDM 01/03/2013
Clinical Reference Laboratory, Inc. Intelligent Transport Cup  (OTC)
K052115 Methamphetamines Toxicology / TDM 01/03/2013
Alere iCup DX Drug Screen Cup  
K052115 Amphetamines Toxicology / TDM 11/27/2012
Alere iCup DX Drug Screen Cup  
K052115 Methamphetamines Toxicology / TDM 11/27/2012
Wondfo Multi-Drug Urine Test Cup  (Cup format)
K122904 Amphetamines Toxicology / TDM 11/16/2012
Wondfo Multi-Drug Urine Test Panel  (Dip Card format)
K122904 Amphetamines Toxicology / TDM 11/16/2012
Clinical Research Laboratory, Inc. Intelligent Transport Cup  (OTC)
K052115 Amphetamines Toxicology / TDM 10/23/2012
Clinical Research Laboratory, Inc. Intelligent Transport Cup  (OTC)
K052115 Methamphetamines Toxicology / TDM 10/23/2012

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