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 K253722. Device: LIAISON PLEX Gastrointestinal Flex Assay. Applicant as listed: Luminex Corporation. Decision date: 2026-05-19.
Source: api.fda.gov · Retrieved 2026-10-21
FDA 510(k) K261280 — BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel
OtherU.S. Food and Drug Administration (FDA)
FDA 510(k) index record K261280. Device: BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel. Applicant as listed: Vivachek Biotech (Hangzhou) Co., Ltd.. Decision date: 2026-05-22.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K253971. Device: Visby Medical Flu and COVID-19 Test. Applicant as listed: Visby Medical, Inc.. Decision date: 2026-05-27.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K253212. Device: XR-Series (XR-10, XR-20) Automated Hematology Analyzers. Applicant as listed: Sysmex America, Inc.. Decision date: 2026-05-27.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260213. Device: BD BACTEC FXI Culture System. Applicant as listed: BD Diagnostic Systems. Decision date: 2026-05-28.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K253882. Device: CorDx Tyfast COVID-19 Ag Rapid Test Rx. Applicant as listed: CorDx, Inc.. Decision date: 2026-06-01.
Source: api.fda.gov · Retrieved 2026-10-21
FDA 510(k) K252899 — Female Culture Device; Male Culture Device; Transfer Device; Access Device
OtherU.S. Food and Drug Administration (FDA)
FDA 510(k) index record K252899. Device: Female Culture Device; Male Culture Device; Transfer Device; Access Device. Applicant as listed: Zhejiang Kindly Medical Device Co., Ltd.. Decision date: 2026-06-02.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260770. Device: LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX. Applicant as listed: DiaSorin, Inc.. Decision date: 2026-06-04.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260754. Device: Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test. Applicant as listed: Assure Tech., LLC. Decision date: 2026-06-05.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K261402. Device: Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System. Applicant as listed: Dexcom, Inc.. Decision date: 2026-06-08.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K254121. Device: Colli-PeeDx Urine Collection Kit. Applicant as listed: DNA Genotek, Inc.. Decision date: 2026-06-10.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K253051. Device: i-STAT hs-TnI cartridge with the i-STAT Alinity System. Applicant as listed: Abbott Point of Care, Inc.. Decision date: 2026-06-11.
Source: api.fda.gov · Retrieved 2026-10-21
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.