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 K251595. Device: COVID-19 Detect Rapid Self -Test. Applicant as listed: InBios International, Inc.. Decision date: 2025-10-12.
Fuente: api.fda.gov · Consultado el 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250159. Device: Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser. Applicant as listed: The Binding Site Group , Ltd.. Decision date: 2025-10-17.
Fuente: api.fda.gov · Consultado el 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250250. Device: ADVIA Centaur Anti-Thyroid Peroxidase II. Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2025-10-17.
Fuente: api.fda.gov · Consultado el 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251289. Device: WELLlife COVID-19 Antigen Test Rx. Applicant as listed: Guangzhou Wondfo Biotech Co., Ltd.. Decision date: 2025-10-22.
Fuente: api.fda.gov · Consultado el 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251749. Device: Flowflex Plus RSV + Flu A/B + COVID Home Test. Applicant as listed: ACON Laboratories, Inc.. Decision date: 2025-10-22.
Fuente: api.fda.gov · Consultado el 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250666. Device: Alegria Flash CTD Screen. Applicant as listed: Zeus Scientific. Decision date: 2025-10-22.
Fuente: api.fda.gov · Consultado el 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K253188. Device: CoaguChek XS Plus System. Applicant as listed: Roche Diagnostics. Decision date: 2025-10-24.
Fuente: api.fda.gov · Consultado el 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K252357. Device: Glucose2. Applicant as listed: Abbott Ireland. Decision date: 2025-10-24.
Fuente: api.fda.gov · Consultado el 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251875. Device: LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system. Applicant as listed: Affinity Biosensors, LLC. Decision date: 2025-10-27.
Fuente: api.fda.gov · Consultado el 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K252393. Device: VITROS Immunodiagnostic Products hs Troponin I Reagent Pack. Applicant as listed: Ortho-Clinical Diagnostics, Inc.. Decision date: 2025-10-29.
Fuente: api.fda.gov · Consultado el 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K252387. Device: Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460). Applicant as listed: Diasorin Molecular, LLC. Decision date: 2025-10-30.
Fuente: api.fda.gov · Consultado el 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K252607. Device: AllTest Urinary Tract Infection Test. Applicant as listed: Hangzhou AllTest Biotech Co., Ltd.. Decision date: 2025-10-30.
Fuente: api.fda.gov · Consultado el 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.