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 K240279. Device: VIDAS TBI (GFAP, UCH-L1). Applicant as listed: bioMerieux, Inc.. Decision date: 2024-05-01.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240636. Device: HemoScreen Hematology Analyzer. Applicant as listed: Pixcell Medical Technologies. Decision date: 2024-05-02.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232454. Device: Viral Transport Media (VTM). Applicant as listed: Alb Luz. Decision date: 2024-05-03.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232416. Device: AUTION EYE AI-4510 Urine Particle Analysis System. Applicant as listed: Arkray, Inc.. Decision date: 2024-05-03.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K234088. Device: Emily's Care Nourish Test System (Model 1). Applicant as listed: Lactation Lab, Inc.. Decision date: 2024-05-03.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K233349. Device: Alinity m HSV 1 & 2 / VZV. Applicant as listed: Abbott Molecular, Inc.. Decision date: 2024-05-03.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240800. Device: Access Intrinsic Factor Ab. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2024-05-03.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232833. Device: HALO AP Dx. Applicant as listed: Indica Labs, Inc.. Decision date: 2024-05-07.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K233581. Device: VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack. Applicant as listed: Ortho Clinical Diagnostics. Decision date: 2024-05-08.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240403. Device: Access BR Monitor. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2024-05-09.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240479. Device: Access OV Monitor. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2024-05-10.
Source: api.fda.gov · Retrieved 2026-10-26
FDA 510(k) K240698 — Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard
OtherU.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240698. Device: Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard. Applicant as listed: Guangzhou Decheng Biotechnology Co., Ltd.. Decision date: 2024-05-10.
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.