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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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* HIGH Complexity designation – All test systems, assays or examinations used in compatibility testing when performed to determine donor/recipient compatibility: recipient & donor ABO group/D (Rho) type/antigen typing, direct antiglobulin test, tests for unexpected antibody detection & identification, & crossmatch procedures are HIGH Complexity. See: Federal Register notice, February 28, 1992 [57 FR 7245].
 
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Document Parent Analyte Analyte Specialty Complexity Effective Date
Mobilab Medical Innovatives Inc, Mobilab Multi-Drug Rapid Test Cup  
CR250738 K233019 Benzodiazepines Toxicology / TDM WAIVED 01/30/2026
Mobilab Medical Innovatives Inc, Mobilab Multi-Drug Rapid Test Cup  
CR250738 K233019 Morphine Toxicology / TDM WAIVED 01/30/2026
Mobilab Medical Innovatives Inc, Mobilab Multi-Drug Rapid Test Cup  
CR250738 K233019 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM WAIVED 01/30/2026
Mobilab Medical Innovatives Inc, Mobilab Multi-Drug Rapid Test Cup  
CR250738 K233019 Oxycodone Toxicology / TDM WAIVED 01/30/2026
Mobilab Medical Innovatives Inc, Mobilab Multi-Drug Rapid Test Cup  
CR250738 K233019 Buprenorphine Toxicology / TDM WAIVED 01/30/2026
Mobilab Medical Innovatives Inc, Mobilab Multi-Drug Rapid Test Cup  
CR250738 K233019 Methadone metabolite (EDDP) Toxicology / TDM WAIVED 01/30/2026
Mobilab Medical Innovatives Inc, Mobilab Multi-Drug Rapid Test Cup  
CR250738 K233019 Nortriptyline Toxicology / TDM WAIVED 01/30/2026
Mobilab Medical Innovatives Inc, Mobilab Multi-Drug Rapid Test Cup  
CR250738 K233019 Secobarbital Toxicology / TDM WAIVED 01/30/2026
Mobilab Medical Innovatives Inc, Mobilab Multi-Drug Rapid Test Panel  
CR250738 K233019 Amphetamines Toxicology / TDM WAIVED 01/30/2026
Mobilab Medical Innovatives Inc, Mobilab Multi-Drug Rapid Test Panel  
CR250738 K233019 Cannabinoids (THC) Toxicology / TDM WAIVED 01/30/2026

*   The maximium 500 devices meeting your search criteria returned. Please narrow your search.

* HIGH Complexity designation – All test systems, assays or examinations used in compatibility testing when performed to determine donor/recipient compatibility: recipient & donor ABO group/D (Rho) type/antigen typing, direct antiglobulin test, tests for unexpected antibody detection & identification, & crossmatch procedures are HIGH Complexity. See: Federal Register notice, February 28, 1992 [57 FR 7245].
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