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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
Roche Diagnostics cobas c 503 analytical unit  {The Binding Site Group Ltd., Freelite Human Lambda Free Kit For use on the Roche Cobas c systems} (Quantitative)
CR250754 K070900 Lambda light chains General Immunology MODERATE 01/27/2026
Roche Diagnostics, cobas c 303  {The Binding Site Group Ltd., Freelite Human Kappa Free Kit For use on the Roche Cobas c systems} (Quantitative)
CR250754 K070900 Kappa light chains General Immunology MODERATE 01/27/2026
Roche Diagnostics, cobas c 303  {The Binding Site Group Ltd., Freelite Human Lambda Free Kit For use on the Roche Cobas c systems} (Quantitative)
CR250754 K070900 Lambda light chains General Immunology MODERATE 01/27/2026
Beckman Coulter AU480 Chemistry Analyzer  {Lin-Zhi International, Inc., LZI Buprenorphine II Enzyme Immunoassay} 
CR250655 K253082 Buprenorphine Toxicology / TDM MODERATE 01/27/2026
Wondfo USA Co., Ltd., SAFElife S-Cup Multi-Drug Urine Test Cup  
CR250736 K252550 Fentanyl Toxicology / TDM WAIVED 01/26/2026
Wondfo USA Co., Ltd., SAFElife S-Cup Multi-Drug Urine Test Cup  
CR250736 K252550 Tramadol Toxicology / TDM WAIVED 01/26/2026
Wondfo USA Co., Ltd., SAFElife S-Cup Multi-Drug Urine Test Cup  
CR250736 K252550 6-Acetylmorphine Toxicology / TDM WAIVED 01/26/2026
Wondfo USA Co., Ltd., SAFElife S-Cup Multi-Drug Urine Test Cup  
CR250736 K252550 Norfentanyl Toxicology / TDM WAIVED 01/26/2026
Wondfo USA Co., Ltd., SAFElife S-Cup Multi-Drug Urine Test Cup Dx  
CR250736 K252550 Amphetamines Toxicology / TDM WAIVED 01/26/2026
Wondfo USA Co., Ltd., SAFElife S-Cup Multi-Drug Urine Test Cup Dx  
CR250736 K252550 Cannabinoids (THC) 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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