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 K222610. Device: Elecsys Anti-Tg. Applicant as listed: Roche Diagnostics. Decision date: 2023-09-15.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231832. Device: Access Myoglobin. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2023-09-18.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K222251. Device: B·R·A·H·M·S CgA II KRYPTOR, B·R·A·H·M·S CgA II KRYPTOR CAL, B·R·A·H·M·S CgA II KRYPTOR QC. Applicant as listed: B.R.A.H.M.S GmbH, Part of Thermo Fisher. Decision date: 2023-09-18.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K221309. Device: AI100 with Shonit. Applicant as listed: Sigtuple Technologies Pvt. , Ltd.. Decision date: 2023-09-19.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223179. Device: Cholestech LDX System. Applicant as listed: Alere San Diego, Inc.. Decision date: 2023-09-20.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K213987. Device: ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls. Applicant as listed: Biokit, S.A.. Decision date: 2023-09-20.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K221817. Device: ALFIS Vitamin D, ALFIS-3 Analyzer. Applicant as listed: Immunostics Inc.,. Decision date: 2023-09-22.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223921. Device: Access CEA. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2023-09-22.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220265. Device: ADVIA Centaur® NT-proBNPII (PBNPII). Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2023-09-24.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K214117. Device: Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer. Applicant as listed: Abbott Diagnostics Technologies AS. Decision date: 2023-09-27.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K222638. Device: Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems. Applicant as listed: Cepheid. Decision date: 2023-09-27.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231007. Device: CEDIA Heroin Metabolite (6-AM) Assay. Applicant as listed: Microgenics Corporation. Decision date: 2023-09-27.
Source: api.fda.gov · Retrieved 2026-10-27
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.