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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
Wondfo USA Co., Ltd., SAFElife S-Cup Multi-Drug Urine Test Cup Dx  
CR250736 K252550 Phencyclidine (PCP) Toxicology / TDM WAIVED 01/26/2026
Wondfo USA Co., Ltd., SAFElife S-Cup Multi-Drug Urine Test Cup Dx  
CR250736 K252550 Cocaine metabolites Toxicology / TDM WAIVED 01/26/2026
Wondfo USA Co., Ltd., SAFElife S-Cup Multi-Drug Urine Test Cup Dx  
CR250736 K252550 Opiates Toxicology / TDM WAIVED 01/26/2026
Wondfo USA Co., Ltd., SAFElife S-Cup Multi-Drug Urine Test Cup Dx  
CR250736 K252550 Methadone Toxicology / TDM WAIVED 01/26/2026
Wondfo USA Co., Ltd., SAFElife S-Cup Multi-Drug Urine Test Cup Dx  
CR250736 K252550 Propoxyphene Toxicology / TDM WAIVED 01/26/2026
Wondfo USA Co., Ltd., SAFElife S-Cup Multi-Drug Urine Test Cup Dx  
CR250736 K252550 Methamphetamines Toxicology / TDM WAIVED 01/26/2026
Wondfo USA Co., Ltd., SAFElife S-Cup Multi-Drug Urine Test Cup Dx  
CR250736 K252550 Morphine Toxicology / TDM WAIVED 01/26/2026
Wondfo USA Co., Ltd., SAFElife S-Cup Multi-Drug Urine Test Cup Dx  
CR250736 K252550 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM WAIVED 01/26/2026
Wondfo USA Co., Ltd., SAFElife S-Cup Multi-Drug Urine Test Cup Dx  
CR250736 K252550 Oxycodone Toxicology / TDM WAIVED 01/26/2026
Wondfo USA Co., Ltd., SAFElife S-Cup Multi-Drug Urine Test Cup Dx  
CR250736 K252550 Fentanyl Toxicology / TDM WAIVED 01/26/2026

*   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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