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 K250117. Device: FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette. Applicant as listed: Assure Tech., LLC. Decision date: 2025-02-13.
Fuente: api.fda.gov · Consultado el 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243396. Device: Aptima SARS-CoV-2 Assay. Applicant as listed: Hologic, Inc.. Decision date: 2025-02-13.
Fuente: api.fda.gov · Consultado el 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K241573. Device: Alinity m Resp-4-Plex. Applicant as listed: Abbott Molecular, Inc.. Decision date: 2025-02-14.
Fuente: api.fda.gov · Consultado el 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242526. Device: Visby Medical Respiratory Health Test. Applicant as listed: Visby Medical, Inc.. Decision date: 2025-02-19.
Fuente: api.fda.gov · Consultado el 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250067. Device: Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro. Applicant as listed: Guangzhou Decheng Biotechnology Co., Ltd.. Decision date: 2025-02-20.
Fuente: api.fda.gov · Consultado el 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243283. Device: Alinity h-series System. Applicant as listed: Abbott Laboratories. Decision date: 2025-02-20.
Fuente: api.fda.gov · Consultado el 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250218. Device: Xpert® FII & FV. Applicant as listed: Cepheid. Decision date: 2025-02-21.
Fuente: api.fda.gov · Consultado el 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K241586. Device: PIVO Pro Needle-free Blood Collection Device. Applicant as listed: Becton Dickinson Infusion Therapy Systems, Inc.. Decision date: 2025-02-27.
Fuente: api.fda.gov · Consultado el 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243738. Device: The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL. Applicant as listed: Thermo Fisher Scientific. Decision date: 2025-02-27.
Fuente: api.fda.gov · Consultado el 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K244043. Device: AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup. Applicant as listed: Hangzhou AllTest Biotech Co., Ltd.. Decision date: 2025-02-27.
Fuente: api.fda.gov · Consultado el 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K241717. Device: E1000 Dx Digital Pathology Solution. Applicant as listed: Shandon Diagnostics Limited. Decision date: 2025-02-28.
Fuente: api.fda.gov · Consultado el 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243730. Device: Xpert C. difficile/Epi. Applicant as listed: Cepheid®. Decision date: 2025-02-28.
Fuente: api.fda.gov · Consultado el 2026-10-24
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.