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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
Leica Biosystems Imaging, Inc., Aperio AT2 DX System  {Aperio ImageScope DX review application} Formalin-fixed, paraffin-embedded (FFPE) tissue slides
CR190069 K190332 Whole slide images of tissue slides Pathology HIGH 02/04/2026
Philips Medical Systems Nederland B.V., Philips IntelliSite Pathology Solution  {Image Management System (IMS)} Formalin-fixed, paraffin-embedded (FFPE) tissue slides
CR170179 DEN160056 Whole slide images of tissue slides Pathology HIGH 02/04/2026
Hamamatsu Photonics K.K., NanoZoomer S360MD Slide scanner system  {NZViewMD Software} Formalin-fixed, paraffin-embedded (FFPE) tissue slides
CR210474 K213883 Whole slide images of tissue slides Pathology HIGH 02/04/2026
Siemens Healthcare Diagnostics Inc. Atellica CH Analyzer  {Siemens Healthcare Diagnostics Inc., Atellica CH Alpha-1-antitrypsin 2 (AAT2)} 
CR260010 K063610 Alpha-1-antitrypsin General Immunology MODERATE 02/03/2026
Siemens Healthcare Diagnostics Inc., Atellica CI analyzer  {Siemens Healthcare Diagnostics Inc., Atellica CH Alpha-1-antitrypsin 2 (AAT2)} 
CR260010 K063610 Alpha-1-antitrypsin General Immunology MODERATE 02/03/2026
Hangzhou Clongene Biotech Co., Ltd., Clungene RSV Antigen Rapid Test  (For use with nasopharyngeal swabs)
CR250611 K253318 Respiratory syncytial virus Virology MODERATE 02/03/2026
MEDTOX Diagnostics, Inc., Labcorp Fentanyl Urine Visual Test  
CR250535 K252684 Norfentanyl Toxicology / TDM MODERATE 02/03/2026
Roche Diagnostics, cobas e 801 Analyzer  {Elecsys Anti-SARS-CoV-2} 
CR260007 K253839 SARS-CoV-2 antibodies General Immunology MODERATE 02/02/2026
Roche Diagnostics, cobas e 402 Analyzer  {Elecsys Anti-SARS-CoV-2} 
CR260007 K253839 SARS-CoV-2 antibodies General Immunology MODERATE 02/02/2026
Roche Diagnostics, cobas e 411 Analyzer  {Elecsys Anti-SARS-CoV-2} 
CR260007 K253839 SARS-CoV-2 antibodies General Immunology MODERATE 02/02/2026

*   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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