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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Document Number K152551
 
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Document Parent Analyte Analyte Specialty Complexity Effective Date
Origin Diagnostics, Origin Instant Dip Drug Test (Buprenorphine)  
CR210100 K152551 Buprenorphine Toxicology / TDM WAIVED 01/19/2022
Origin Diagnostics, Origin Instant Dip Drug Test (Butalbital)  
CR210100 K152551 Barbiturates Toxicology / TDM WAIVED 01/19/2022
Origin Diagnostics, Origin Instant Dip Drug Test (Morphine)  
CR210100 K152551 Morphine Toxicology / TDM WAIVED 01/19/2022
Hospital Connect Inc. Serenity Test Cup  
CR200464 K152551 Barbiturates Toxicology / TDM WAIVED 07/02/2021
Hospital Connect Inc. Serenity Test Cup  
CR200464 K152551 Morphine Toxicology / TDM WAIVED 07/02/2021
Hospital Connect Inc. Serenity Test Cup  
CR200464 K152551 Buprenorphine Toxicology / TDM WAIVED 07/02/2021
Origin Diagnostics Origin Instant Drug Test (Buprenorphine)  
CR190725 K152551 Buprenorphine Toxicology / TDM WAIVED 01/06/2020
Origin Diagnostics Origin Instant Drug Test (Butalbital)  
CR190725 K152551 Barbiturates Toxicology / TDM WAIVED 01/06/2020
Origin Diagnostics Origin Instant Drug Test (Morphine)  
CR190725 K152551 Morphine Toxicology / TDM WAIVED 01/06/2020
Clinical Reference Laboratory, CRLstat Onsite Buprenorphine Drug Test Cup  
CR190326 K152551 Buprenorphine Toxicology / TDM WAIVED 07/02/2019

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