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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Analyte pH Complexity waived
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Document Analyte Analyte Specialty Effective Date
Clinical Reference Laboratory, Inc. Intelligent Transport Cup  (OTC)
K052115 Phencyclidine (PCP) Toxicology / TDM 01/03/2013
Clinical Reference Laboratory, Inc. Intelligent Transport Cup  (OTC)
K052115 Methamphetamines Toxicology / TDM 01/03/2013
Clinical Reference Laboratory, Inc. Intelligent Transport Cup  (OTC)
K052115 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 01/03/2013
Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug Screen Cassette Tests  
K123080 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 11/29/2012
Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug Screen Dip Card Tests  
K123080 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 11/29/2012
Alere iCup DX Drug Screen Cup  
K052115 Amphetamines Toxicology / TDM 11/27/2012
Alere iCup DX Drug Screen Cup  
K052115 Phencyclidine (PCP) Toxicology / TDM 11/27/2012
Alere iCup DX Drug Screen Cup  
K052115 Methamphetamines Toxicology / TDM 11/27/2012
Alere iCup DX Drug Screen Cup  
K052115 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 11/27/2012
Wondfo Multi-Drug Urine Test Cup  (Cup format)
K122904 Amphetamines Toxicology / TDM 11/16/2012

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