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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Analyte Methamphetamine/Amphetamine Complexity waived Effective Date To 11/29/2014
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Document Parent Analyte Analyte Specialty Effective Date
Alere Tox Screen Drugs of Abuse Test Cup  
CR140327 K050878 Methamphetamine/amphetamine Toxicology / TDM 10/02/2014
1 Step Detect Associates DTX Drug Test Cup Integrated E-Z- Split Key Cup II  
K050878   Methamphetamine/amphetamine Toxicology / TDM 04/30/2009
WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup  
K050878   Methamphetamine/amphetamine Toxicology / TDM 08/21/2006
ACON Laboratories, On Call Multi-Drug Home Test Cup  
K050878   Methamphetamine/amphetamine Toxicology / TDM 06/10/2005
PHAMATECH AT HOME DRUG TEST (MODEL 9150X)  
K030447   Methamphetamine/amphetamine Toxicology / TDM 05/01/2003
PHAMATECH AT HOME DRUG TEST (MODEL 9150T)  
K010655   Methamphetamine/amphetamine Toxicology / TDM 04/04/2001

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