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 K251753. Device: GenaCheck COVID-19 Rapid Self-Test. Applicant as listed: Genabio Diagnostics, Inc.. Decision date: 2025-09-05.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243846. Device: Access anti-HAV. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2025-09-09.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251040. Device: MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test. Applicant as listed: Guangzhou Decheng Biotechnology Co., Ltd.. Decision date: 2025-09-09.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K252580. Device: iQ200 Series. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2025-09-10.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243926. Device: Vivatmo pro-S. Applicant as listed: Bosch Healthcare Solutions GmbH. Decision date: 2025-09-11.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K252520. Device: SEFRIA Hydrocodone Oral Fluid. Applicant as listed: Immunalysis Corporation. Decision date: 2025-09-11.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K252554. Device: Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup. Applicant as listed: Vivachek Biotech (Hangzhou) Co., Ltd.. Decision date: 2025-09-12.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250609. Device: Sober Self-Test. Applicant as listed: Sober Ip, LLC. Decision date: 2025-09-15.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K241868. Device: xR IVD. Applicant as listed: Tempus AI, Inc.. Decision date: 2025-09-19.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250408. Device: Alegria Flash ENA Screen. Applicant as listed: Zeus Scientific. Decision date: 2025-09-19.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250205. Device: Babio® Virus Transport Kit (Non-inactivating). Applicant as listed: Jinan Babio Biotechnology Co., Ltd.. Decision date: 2025-09-22.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K252062. Device: The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL. Applicant as listed: Thermo Fisher Scientific. Decision date: 2025-09-25.
Source: api.fda.gov · Retrieved 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.