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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 Effective Date To 04/20/2014
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Document Parent Analyte Analyte Specialty Effective Date
Devon Medical Products CentralCheck Multiple Drug Cup Test  (Professional Use)
K071489   Amphetamines Toxicology / TDM 08/05/2013
Devon Medical Products CentralCheck Multiple Drug Cup Test  (Professional Use)
K071489   Methamphetamines Toxicology / TDM 08/05/2013
Jant Pharmacal Corp. Accutest Drug Test Cup  (Professional Use)
K071489   Amphetamines Toxicology / TDM 08/05/2013
Jant Pharmacal Corp. Accutest Drug Test Cup  (Professional Use)
K071489   Methamphetamines Toxicology / TDM 08/05/2013
Alere iScreen DX Multi-Drugs of Abuse Dip Test  
K022355   Amphetamines Toxicology / TDM 08/01/2013
Alere iScreen DX Multi-Drugs of Abuse Dip Test  
K022355   Methamphetamines Toxicology / TDM 08/01/2013
Alere iCup Dx 14  (Cassette Dip Card format)
K122633   Amphetamines Toxicology / TDM 07/29/2013
Alere iCup Dx 14  (Cassette Dip Card format)
K122633   Methamphetamines Toxicology / TDM 07/29/2013
Confirm Biosciences RELI ON Multi-Drug of Abuse Urine Cup Test  
K063545   Amphetamines Toxicology / TDM 07/19/2013
Confirm Biosciences RELI ON Multi-Drug of Abuse Urine Cup Test  
K063545   Methamphetamines Toxicology / TDM 07/19/2013

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