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 K243872. Device: BD Veritor System for SARS-CoV-2. Applicant as listed: Becton, Dickinson and Company. Decision date: 2025-06-16.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243561. Device: Nano-Check Influenza+COVID-19 Dual Test. Applicant as listed: Nano-Ditech Corporation. Decision date: 2025-06-17.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251634. Device: LZI Fentanyl III Enzyme Immunoassay. Applicant as listed: Lin-Zhi International, Inc.. Decision date: 2025-06-18.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243168. Device: Alinity i Rubella IgG. Applicant as listed: Abbott Laboratories. Decision date: 2025-06-20.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250968. Device: PathPresenter Clinical Viewer. Applicant as listed: Pathpresenter Corporation. Decision date: 2025-06-20.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242981. Device: Atellica IM Thyroglobulin (Tg). Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2025-06-20.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242911. Device: Medconn Glycated Hemoglobin Test system. Applicant as listed: Shanghai Medconn Medical Technology Co., Ltd.. Decision date: 2025-06-20.
Source: api.fda.gov · Retrieved 2026-10-23
FDA 510(k) index record K242843. Device: The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL.. Applicant as listed: Thermo Fisher Scientific. Decision date: 2025-06-20.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250885. Device: Ceftobiprole BPR 5 µg Disc. Applicant as listed: Liofilchem, Inc.. Decision date: 2025-06-23.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250943. Device: Sysmex XR-Series (XR-10) Automated Hematology Analyzer. Applicant as listed: Sysmex America, Inc.. Decision date: 2025-06-25.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251371. Device: Sysmex XR-Series (XR-20) Automated Hematology Analyzer. Applicant as listed: Sysmex America, Inc.. Decision date: 2025-06-25.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243391. Device: AISight Dx. Applicant as listed: PathAI, Inc.. Decision date: 2025-06-26.
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.