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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
Aceso Laboratories, Inc., Atida Early Pregnancy Test  
CR250768 K234152 hCG, Urine Endocrinology WAIVED 02/06/2026
Newfoundland Diagnostics Ltd, At-home Menopause Test  
CR250766 CR250766 Follicle stimulating hormone (FSH) Endocrinology WAIVED 02/06/2026
HY-VEE, INC., Hy-Vee Ovulation Kit  {Hy-Vee Analog Pregnancy Rapid Test} 
CR250765 K230038 Urine hCG by visual color comparison tests Endocrinology WAIVED 02/06/2026
HY-VEE, INC., Hy-Vee Ovulation Kit  {Hy-Vee Ovulation Rapid Test} 
CR250765 CR250765 Luteinizing hormone (LH) Endocrinology WAIVED 02/06/2026
HY-VEE, INC., Hy-Vee Analog Pregnancy Rapid Test  
CR250765 K230038 Urine hCG by visual color comparison tests Endocrinology WAIVED 02/06/2026
HY-VEE, INC., Hy-Vee Ovulation Rapid Test  
CR250765 CR250765 Luteinizing hormone (LH) Endocrinology WAIVED 02/06/2026
Ortho Clinical Diagnostics, VITROS 3600 Immunodiagnostic System  {VITROS Immunodiagnostic Products hs Troponin I Reagent Pack} 
CR250729 K252393 Troponin-I (cardiac) General Chemistry MODERATE 02/06/2026
Ortho Clinical Diagnostics, VITROS XT 7600 Integrated System  {VITROS Immunodiagnostic Products hs Troponin I Reagent Pack} 
CR250729 K252393 Troponin-I (cardiac) General Chemistry MODERATE 02/06/2026
DiaSorin Inc., LIAISON XL Analyzer  {DiaSorin Inc., LIAISON QuantiFERON-TB Gold Plus II Assay} (Interferon-gamma; chemiluminescent immuno-assay)
CR250472 P180047/S039 Cytokines General Immunology HIGH 02/05/2026
DiaSorin Inc., LIAISON XS Analyzer  {DiaSorin Inc., LIAISON QuantiFERON-TB Gold Plus II Assay} (Interferon-gamma; chemiluminescent immuno-assay)
CR250472 P180047/S039 Cytokines General Immunology HIGH 02/05/2026

*   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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