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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
Randox Laboratories Ltd., Evidence MultiStat  {Evidence MultiSTAT DOA Urine MultiPlex} 
CR250639 K250741 Amphetamines Toxicology / TDM MODERATE 01/30/2026
Randox Laboratories Ltd., Evidence MultiStat  {Evidence MultiSTAT DOA Urine MultiPlex} 
CR250639 K250741 Cannabinoids (THC) Toxicology / TDM MODERATE 01/30/2026
Randox Laboratories Ltd., Evidence MultiStat  {Evidence MultiSTAT DOA Urine MultiPlex} 
CR250639 K250741 Cocaine metabolites Toxicology / TDM MODERATE 01/30/2026
Randox Laboratories Ltd., Evidence MultiStat  {Evidence MultiSTAT DOA Urine MultiPlex} 
CR250639 K250741 Opiates Toxicology / TDM MODERATE 01/30/2026
Randox Laboratories Ltd., Evidence MultiStat  {Evidence MultiSTAT DOA Urine MultiPlex} 
CR250639 K250741 Fentanyl Toxicology / TDM MODERATE 01/30/2026
Randox Laboratories Ltd., Evidence MultiStat  {Evidence MultiSTAT DOA Urine MultiPlex} (Benzodiazepines 2)
CR250639 K250741 Benzodiazepines Toxicology / TDM MODERATE 01/30/2026
Copan Wasp Srl, PhenoMATRIX  {Images of solid culture media plates streaked with microbiological samples derived from the human body} (For use with the WASPLab instrument)
CR250305 K251511 Aerobic &/or anaerobic organisms-unlimited sources Bacteriology HIGH 01/30/2026
Truvian Health, TruVerus  {Core Metabolic} 
CR250248 K251157 Albumin General Chemistry MODERATE 01/30/2026
Truvian Health, TruVerus  {Core Metabolic} 
CR250248 K251157 Protein, total General Chemistry MODERATE 01/30/2026
Truvian Health, TruVerus  {Core Metabolic} 
CR250248 K251157 Glucose General Chemistry MODERATE 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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