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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 Effective Date To 04/18/2015
 
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Document Parent Analyte Analyte Specialty Effective Date
Guangzhou Wondfo Biotech Co., Ltd. CR3 Keyless Split Sample Cup Morphine - Methamphetamine  
CR150113 K150602 Methamphetamines Toxicology / TDM 04/09/2015
Medical Distribution Group Inc., Identify Home Drug Testing Device Test Cards  
CR150101 K130463 Amphetamines Toxicology / TDM 03/31/2015
Medical Distribution Group Inc., Identify Home Drug Testing Device Test Cards  
CR150101 K130463 Methamphetamines Toxicology / TDM 03/31/2015
Medical Distribution Group Inc., Identify Home Drug Testing Device Test Cups  
CR150101 K130463 Amphetamines Toxicology / TDM 03/31/2015
Medical Distribution Group Inc., Identify Home Drug Testing Device Test Cups  
CR150101 K130463 Methamphetamines Toxicology / TDM 03/31/2015
W.H.P.M., Inc. First Sign® Drug of Abuse Cup Test  
CR150048 K150162 Methamphetamines Toxicology / TDM 02/26/2015
W.H.P.M., Inc. First Sign® Drug of Abuse Dip Card Test  
CR150048 K150162 Methamphetamines Toxicology / TDM 02/26/2015
Healgen Amphetamine Test Cassette  
CR140435 K143187 Amphetamines Toxicology / TDM 01/28/2015
Healgen Amphetamine Test Cup  
CR140435 K143187 Amphetamines Toxicology / TDM 01/28/2015
Healgen Amphetamine Test Dip Card  
CR140435 K143187 Amphetamines Toxicology / TDM 01/28/2015

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