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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
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
Beckman Coulter AU680 Clinical Chemistry Analyzer  {Diazyme Laboratories, Inc., Diazyme Oxalate Enzymatic Assay} 
CR250770 CR250770 Oxalate General Chemistry HIGH 01/30/2026
HY-VEE, INC., Hy-Vee 6 Days Sooner/Early Detection Pregnancy Test  
CR250764 K240643 Urine hCG by visual color comparison tests Endocrinology WAIVED 01/30/2026
HY-VEE, INC., Hy-Vee Digital Pregnancy Rapid Test  
CR250763 K222305 hCG, Urine Endocrinology WAIVED 01/30/2026
Mobilab Medical Innovatives Inc, Mobilab Fentanyl Urine Test Cassette  
CR250741 K233417 Fentanyl Toxicology / TDM WAIVED 01/30/2026
Mobilab Medical Innovatives Inc, Mobilab Multi-Drug Rapid Test Cup  
CR250738 K233019 Cocaine metabolites Toxicology / TDM WAIVED 01/30/2026
Mobilab Medical Innovatives Inc, Mobilab Multi-Drug Rapid Test Cup  
CR250738 K233019 Methadone Toxicology / TDM WAIVED 01/30/2026
Mobilab Medical Innovatives Inc, Mobilab Multi-Drug Rapid Test Cup  
CR250738 K233019 Methamphetamines 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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