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 K260787. Device: FebriDx Bacterial/Non-bacterial Assay. Applicant as listed: Lumos Diagnostics, Inc.. Decision date: 2026-03-24.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260041. Device: MDx-Chex for BCP. Applicant as listed: Streck, LLC. Decision date: 2026-03-27.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260812. Device: Francisella tularensis Real-time PCR Assay. Applicant as listed: Centers for Disease Control and Prevention. Decision date: 2026-03-30.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250516. Device: SMART M-CELL PRP Concentration System. Applicant as listed: Miracell Co., Ltd.. Decision date: 2026-04-02.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250518. Device: SMART M-CELL Bone Marrow Concentration System. Applicant as listed: Miracell Co., Ltd.. Decision date: 2026-04-02.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260026. Device: Tina-quant Cardiac high sensitivity CRP III. Applicant as listed: Roche Diagnostics. Decision date: 2026-04-02.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260184. Device: Onclarity Self-Collection Kit. Applicant as listed: Becton, Dickinson and Company. Decision date: 2026-04-02.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260049. Device: Elecsys Anti-HBc IgM. Applicant as listed: Roche Diagnostics. Decision date: 2026-04-07.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260048. Device: Elecsys Anti-HAV IgM. Applicant as listed: Roche Diagnostics. Decision date: 2026-04-07.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260046. Device: Elecsys Anti-HBc II. Applicant as listed: Roche Diagnostics. Decision date: 2026-04-07.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K252228. Device: Seaman Pro/Seaman. Applicant as listed: Checkcells, Inc.. Decision date: 2026-04-09.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K252506. Device: BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder. Applicant as listed: Becton, Dickinson and Company. Decision date: 2026-04-10.
Source: api.fda.gov · Retrieved 2026-10-20
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.