Published Technical Documents
Standards, guidance and application literature from the bodies and manufacturers that publish it. Every entry links to the document page itself and quotes the sentence that says what it covers.
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U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243489. Device: Alinity m EBV (09N43-095). Applicant as listed: Abbott Molecular, Inc.. Decision date: 2025-07-28.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243455. Device: cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems. Applicant as listed: Roche Molecular Systems, Inc.. Decision date: 2025-07-31.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243483. Device: Access hsTnI. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2025-08-01.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243496. Device: MycoMEIA Aspergillus Assay. Applicant as listed: Pearl Diagnostics, Inc.. Decision date: 2025-08-01.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243462. Device: Diazyme Colorimetric Lithium Assay. Applicant as listed: Diazyme Laboratories, Inc.. Decision date: 2025-08-01.
Source: api.fda.gov · Retrieved 2026-10-23
FDA 510(k) K251713 — BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)
OtherU.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251713. Device: BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL). Applicant as listed: Becton, Dickinson and Company. Decision date: 2025-08-08.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251879. Device: Sulopenem SPM 2 µg. Applicant as listed: Liofilchem. Decision date: 2025-08-12.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251495. Device: MBT Compass HT CA Software; MBT FAST Shuttle US IVD. Applicant as listed: Bruker Daltonics GmbH & Co. KG. Decision date: 2025-08-13.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243544. Device: BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini. Applicant as listed: Biofire Diagnostics, LLC. Decision date: 2025-08-14.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251526. Device: FilmArray GI Control Panel M238. Applicant as listed: Maine Molecular Quality Controls, Inc.. Decision date: 2025-08-14.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251972. Device: Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180). Applicant as listed: Healgen Scientific,, LLC. Decision date: 2025-08-15.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250036. Device: MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL). Applicant as listed: Beckman Coulter, Inc.. Decision date: 2025-08-15.
Source: api.fda.gov · Retrieved 2026-10-23
Key takeaways
Every item here is a technical document its publisher made public: a standards-body scope page, a regulator guidance document, or a manufacturer application note or journal article. The entry links to that page and quotes the sentence describing what the document covers. It is not a record of work IVDmap has done.
Target audienceImplementation teams, labs, procurement managers
Review and references
Compiled from public manufacturer materials and regulatory sources. Not independently verified and not reviewed by a named clinician.
2026-10-01
2026-10-09
professional use
Every document below is published by the body named on it, and this page links to that page. Nothing here is a record of work IVDmap has done.