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 K260755. Device: OptraSCAN System. Applicant as listed: Optrascan, Inc.. Decision date: 2026-07-02.
Fuente: api.fda.gov · Consultado el 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260160. Device: VITEK REVEAL GN AST Assay and VITEK REVEAL AST System. Applicant as listed: bioMerieux, Inc.. Decision date: 2026-07-08.
Fuente: api.fda.gov · Consultado el 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260917. Device: cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems. Applicant as listed: Roche Molecular Systems, Inc.. Decision date: 2026-07-08.
Fuente: api.fda.gov · Consultado el 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K261962. Device: SmartGuard Technology; Predictive Low Glucose Technology. Applicant as listed: Medtronic MiniMed. Decision date: 2026-07-09.
Fuente: api.fda.gov · Consultado el 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K261212. Device: Flowflex Plus RSV + Flu A/B + COVID Rapid Test. Applicant as listed: ACON Laboratories, Inc.. Decision date: 2026-07-10.
Fuente: api.fda.gov · Consultado el 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K254295. Device: Sofia Lyme FIA; Sofia 2 Campylobacter FIA. Applicant as listed: Ortho-Clinical Diagnostics, Inc. (QuidelOrtho). Decision date: 2026-07-10.
Fuente: api.fda.gov · Consultado el 2026-10-21
FDA 510(k) K253606 — NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system
OtherU.S. Food and Drug Administration (FDA)
FDA 510(k) index record K253606. Device: NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system. Applicant as listed: Hamamatsu Photonics K.K.. Decision date: 2026-07-15.
Fuente: api.fda.gov · Consultado el 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260021. Device: cobas® BV/CV. Applicant as listed: Roche Molecular Systems, Inc.. Decision date: 2026-07-16.
Fuente: api.fda.gov · Consultado el 2026-10-20
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251952. Device: Virasight. Applicant as listed: Virasoft Corporation. Decision date: 2026-07-17.
Fuente: api.fda.gov · Consultado el 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K261475. Device: BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit. Applicant as listed: Biofire Defense, LLC. Decision date: 2026-07-17.
Fuente: api.fda.gov · Consultado el 2026-10-20
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K261984. Device: AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup. Applicant as listed: Assure Tech., LLC. Decision date: 2026-07-17.
Fuente: api.fda.gov · Consultado el 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260591. Device: NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond (Amygdalus communis);Capture Reagent F078, Bos d 8 Casein, Milk; Capture Reagent F080, Lobster (Homarus gammarus);Capture Reagent F422, Ara h 1, Peanut. Applicant as listed: Hycor Biomedical. Decision date: 2026-07-21.
Fuente: api.fda.gov · Consultado el 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.