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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Analyte Methamphetamines Complexity waived Effective Date To 08/30/2014
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Document Parent Analyte Analyte Specialty Effective Date
IND Diagnostic IND Home Drug Test - Multi-Panel Strip Format  
K121231   Methamphetamines Toxicology / TDM 08/02/2012
Wondfo Multi-Drug Urine Test Cup  (Cup format)
K121166   Methamphetamines Toxicology / TDM 07/24/2012
Wondfo Multi-Drug Urine Test Panel  (Dip Card format)
K121166   Methamphetamines Toxicology / TDM 07/24/2012
Ultimate Analysis Cup UA Cups  
K110515   Methamphetamines Toxicology / TDM 07/13/2012
CLIAwaived Inc. Single Drug Dipstick Test  
K022355   Methamphetamines Toxicology / TDM 07/03/2012
CLIAwaived Inc. Rapid Dip Drug Test  
K022355   Methamphetamines Toxicology / TDM 07/03/2012
BTNX Inc Rapid Response X-Press Drug Test (MET/Methamphetamine)  (Dip Card format)
K112071   Methamphetamines Toxicology / TDM 05/29/2012
BTNX Inc Rapid Response X-Press Drug Test (MET/Methamphetamine)  (Cup format)
K112071   Methamphetamines Toxicology / TDM 05/29/2012
Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug Screen Cassette Tests  
K121339   Methamphetamines Toxicology / TDM 05/22/2012
Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug Screen Dip Card Tests  
K121339   Methamphetamines Toxicology / TDM 05/22/2012

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