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.
Filter documents
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K213348. Device: BOND MMR Antibody Panel. Applicant as listed: Leica Biosystems Newcastle, Ltd.. Decision date: 2023-02-21.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223810. Device: Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH). Applicant as listed: Sb-Kawasumi Laboratories, Inc.. Decision date: 2023-02-24.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K211181. Device: Idylla MSI Test. Applicant as listed: Biocartis NV. Decision date: 2023-02-27.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K230038. Device: MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream). Applicant as listed: Guangzhou Decheng Biotechnology Co., Ltd.. Decision date: 2023-02-28.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K222280. Device: Bigfoot Unity® Diabetes Management System. Applicant as listed: Bigfoot Biomedical, Inc.. Decision date: 2023-03-01.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223602. Device: Traumatic brain injury (TBI) test. Applicant as listed: Abbott Laboratories. Decision date: 2023-03-02.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K222379. Device: Alinity m STI Assay. Applicant as listed: Abbott Molecular, Inc.. Decision date: 2023-03-03.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K222447. Device: FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System. Applicant as listed: Abbott Diabetes Care, Inc.. Decision date: 2023-03-03.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K230236. Device: Lyra Influenza A+B Assay. Applicant as listed: Quidel Corporation. Decision date: 2023-03-03.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220407. Device: Visby Medical Sexual Health Test. Applicant as listed: Visby Medical. Decision date: 2023-03-07.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K221198. Device: Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL. Applicant as listed: Thermo Fisher Scientific. Decision date: 2023-03-10.
Source: api.fda.gov · Retrieved 2026-10-28
FDA 510(k) K222478 — BD Vacutainer® Luer-Lok Access Device, BD Vacutainer® Blood Transfer Device
OtherU.S. Food and Drug Administration (FDA)
FDA 510(k) index record K222478. Device: BD Vacutainer® Luer-Lok Access Device, BD Vacutainer® Blood Transfer Device. Applicant as listed: Becton, Dickinson and Company. Decision date: 2023-03-10.
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.