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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 08/27/2014
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Document Parent Analyte Analyte Specialty Effective Date
Healgen mAMP One Step Methamphetamine Test Strip  
K140546   Methamphetamines Toxicology / TDM 06/09/2014
Healgen mAMP One Step Methamphetamine Test Cassette  
K140546   Methamphetamines Toxicology / TDM 06/09/2014
Healgen mAMP One Step Methamphetamine Test Cup  
K140546   Methamphetamines Toxicology / TDM 06/09/2014
Healgen mAMP One Step Methamphetamine Test Dip Card  
K140546   Methamphetamines Toxicology / TDM 06/09/2014
Biotech Screening Correction Cup  (Cup format)
K122904   Amphetamines Toxicology / TDM 06/04/2014
Biotech Screening Correction Cup  
K122904   Methamphetamines Toxicology / TDM 06/04/2014
Native Diagnostics International, DrugSmart Dip Single/Multi-Panel Drug Screen Cassette Tests  
CR140134 K102203 Amphetamines Toxicology / TDM 05/12/2014
Native Diagnostics International, DrugSmart Dip Single/Multi-Panel Drug Screen Cassette Tests  
CR140134 K102203 Methamphetamines Toxicology / TDM 05/12/2014
Native Diagnostics International, DrugSmart Dip Single/Multi-Panel Drug Screen Dip Card Tests  
CR140134 K102203 Amphetamines Toxicology / TDM 05/12/2014
Native Diagnostics International, DrugSmart Dip Single/Multi-Panel Drug Screen Dip Card Tests  
CR140134 K102203 Methamphetamines Toxicology / TDM 05/12/2014

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