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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 Panel  
CR250738 K233019 Nortriptyline Toxicology / TDM WAIVED 01/30/2026
Mobilab Medical Innovatives Inc, Mobilab Multi-Drug Rapid Test Panel  
CR250738 K233019 Secobarbital Toxicology / TDM WAIVED 01/30/2026
Mobilab Medical Innovatives Inc, Mobilab Multi-Drug Rapid Test Cup  
CR250738 K233019 Amphetamines Toxicology / TDM WAIVED 01/30/2026
Mobilab Medical Innovatives Inc, Mobilab Multi-Drug Rapid Test Cup  
CR250738 K233019 Cannabinoids (THC) Toxicology / TDM WAIVED 01/30/2026
Mobilab Medical Innovatives Inc, Mobilab Multi-Drug Rapid Test Cup  
CR250738 K233019 Phencyclidine (PCP) Toxicology / TDM WAIVED 01/30/2026
2San LLC, 2San UTI Test  
CR250724 K252607 Urine qualitative dipstick nitrite Urinalysis WAIVED 01/30/2026
2San LLC, 2San UTI Test  
CR250724 K252607 Leukocyte esterase, urinary Urinalysis WAIVED 01/30/2026
Newfoundland Diagnostics Ltd., Newfoundland At-Home Fecal Occult Blood Test  
CR250758 K110309 Fecal occult blood General Chemistry WAIVED 01/27/2026
Carolina Liquid Chemistries Corp., CLC 1600 Chemistry Analyzer  {Kamiya Biomedical Company, K-Assay Ferritin} 
CR250755 K050944 Ferritin General Chemistry MODERATE 01/27/2026
Roche Diagnostics cobas c 503 analytical unit  {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

*   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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