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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Analyte Morphine Complexity waived Effective Date To 10/25/2014
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Document Parent Analyte Analyte Specialty Effective Date
Revolution Diagnostics Corp. AccuSeal Pro Instant Test Cup  
K071489   Morphine Toxicology / TDM 10/11/2012
Medimpex United, Inc. MedimpexQ Test Multi X Drug Cup Test  
K071489   Morphine Toxicology / TDM 10/05/2012
IND Diagnostic IND Home Morphine Test - Cassette Format  
K121231   Morphine Toxicology / TDM 08/02/2012
IND Diagnostic IND Home Drug Test - Multi-Panel Cassette Format  
K121231   Morphine Toxicology / TDM 08/02/2012
IND Diagnostic IND Home Morphine Test - Strip Format  
K121231   Morphine Toxicology / TDM 08/02/2012
IND Diagnostic IND Home Drug Test - Multi-Panel Strip Format  
K121231   Morphine Toxicology / TDM 08/02/2012
Wondfo Multi-Drug Urine Test Cup  (Cup format)
K121166   Morphine Toxicology / TDM 07/24/2012
Wondfo Multi-Drug Urine Test Panel  (Dip Card format)
K121166   Morphine Toxicology / TDM 07/24/2012
Ultimate Analysis Cup UA Cups  
K110515   Morphine Toxicology / TDM 07/13/2012
BTNX Inc Rapid Response X-Press Drug Test (MOP/Morphine)  (Cup format)
K112071   Morphine Toxicology / TDM 05/29/2012

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