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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 177 Results
Analyte Opiates Complexity waived Effective Date To 10/25/2014
 
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Document Parent Analyte Analyte Specialty Effective Date
Chemtron Biotech, Inc. Chemtrue Multi-Panel Drug Screen Dip Card with OPI 2000 Tests  
CR140334 K142396 Opiates Toxicology / TDM 10/09/2014
Alere Tox Screen Drugs of Abuse Test Cup  
CR140327 K050878 Opiates Toxicology / TDM 10/02/2014
Ekla Corporation NOVAPLUS MDMA and OPI Drug Test Cup  {Urine} (Cup format)
CR140225 K130275 Opiates Toxicology / TDM 07/16/2014
Kasaac Laboratories Drug Test  
CR140159 K071489 Opiates Toxicology / TDM 07/09/2014
Biotech Screening., LLC., Biotech Screening Corrections Cup  (Cup format)
CR140243 K130665 Opiates Toxicology / TDM 07/07/2014
Kassac Laboratories Multi (MDMA and OPI) Drug Test Cup  {Urine} (Cup format)
CR140183 K130275 Opiates Toxicology / TDM 06/19/2014
First Check Diagnostics LLC, Home Drug Test  
CR140177 K082898 Opiates Toxicology / TDM 06/10/2014
Kasaac Laboratories, Inc. Kasaac Laboratories Buprenorphine Drug Test  
CR140181 K122064 Opiates Toxicology / TDM 06/03/2014
Native Diagnostics International, DrugSmart Dip Single/Multi-Panel Drug Screen Cassette Tests  
CR140134 K102203 Opiates Toxicology / TDM 05/12/2014
Native Diagnostics International, DrugSmart Dip Single/Multi-Panel Drug Screen Dip Card Tests  
CR140134 K102203 Opiates Toxicology / TDM 05/12/2014

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