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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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1 to 10 of 163 Results
Analyte Methadone Complexity waived Effective Date To 11/21/2014
 
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Document Parent Analyte Analyte Specialty Effective Date
Native Diagnostics International DrugSmart Dip Multi-Panel Drug Screen Dip Card Tests  
CR140416 K142396 Methadone Toxicology / TDM 11/13/2014
Native Diagnostics International DrugSmart Dip Multi-Panel Drug Screen Dip Card with OPI 2000 Tests  
CR140416 K142396 Methadone Toxicology / TDM 11/13/2014
CVS/Pharmacy Inc. CVS Home Drug Test  
CR140399 K052115 Methadone Toxicology / TDM 10/31/2014
Chemtron Biotech, Inc. Chemtrue Multi-Panel Drug Screen Dip Card Tests  
CR140334 K142396 Methadone Toxicology / TDM 10/09/2014
Chemtron Biotech, Inc. Chemtrue Multi-Panel Drug Screen Dip Card with OPI 2000 Tests  
CR140334 K142396 Methadone Toxicology / TDM 10/09/2014
CLIAwaived Inc. Rapid Drug Test Cup  (Cassette Dip Card format)
CR140332 K122633 Methadone Toxicology / TDM 09/18/2014
MP Biomedicals, LLC MP On-Site Drugs of Abuse Test Cup  
CR140292 K071489 Methadone Toxicology / TDM 08/22/2014
Co-Innovation Biotech Co., Ltd. Single/Multi-drug Test Cup  
CR140014 K140748 EDDP (methadone metabolite) Toxicology / TDM 08/21/2014
Co-Innovation Biotech Co., Ltd. Single/Multi-drug Test Dipcard  
CR140014 K140748 EDDP (methadone metabolite) Toxicology / TDM 08/21/2014
Wondfo USA Co., Ltd CLIA Screen Multi-Drug Urine Test Panel  
CR140143 K130665 Methadone Toxicology / TDM 08/20/2014

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