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 K262432. Device: CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test. Applicant as listed: CorDx, Inc.. Decision date: 2026-10-14.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K262576. Device: twiist Loop Algorithm. Applicant as listed: Deka Research and Development Corp.. Decision date: 2026-10-15.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260827. Device: Oncomine Dx Express Test. Applicant as listed: Life Technologies Corporation. Decision date: 2026-10-15.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K252344. Device: BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST). Applicant as listed: Becton, Dickinson and Company. Decision date: 2026-10-16.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K262368. Device: B. anthracis Real-time PCR Assay. Applicant as listed: Centers for Disease Control and Prevention. Decision date: 2026-10-07.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260687. Device: VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System.. Applicant as listed: Vivachek Biotech (Hangzhou) Co., Ltd.. Decision date: 2026-10-09.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K192118. Device: CRP Vario. Applicant as listed: SENTINEL CH. SpA. Decision date: 2019-11-08.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K191286. Device: CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System. Applicant as listed: Ascensia Diabetes Care. Decision date: 2019-11-08.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K190661. Device: Omics Core. Applicant as listed: Nanthealth, Inc.. Decision date: 2019-11-09.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K191161. Device: xTAG Gastrointestinal Pathogen Panel (GPP). Applicant as listed: Luminex Molecular Diagnostics, Inc.. Decision date: 2019-11-12.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K192355. Device: MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL). Applicant as listed: Beckman Coulter, Inc.. Decision date: 2019-11-14.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K192842. Device: HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High. Applicant as listed: Eurotrol B.V.. Decision date: 2019-11-15.
Source: api.fda.gov · Retrieved 2026-10-19
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.