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 K250358. Device: BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System. Applicant as listed: Becton, Dickinson and Company. Decision date: 2025-10-31.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K252484. Device: cobas HCV. Applicant as listed: Roche Molecular Systems, Inc.. Decision date: 2025-11-03.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K252481. Device: cobas CMV. Applicant as listed: Roche Molecular Systems, Inc.. Decision date: 2025-11-03.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K252627. Device: Lyme-ID IgG Test; Bio-ID800. Applicant as listed: Inanovate, Inc.. Decision date: 2025-11-14.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251538. Device: Status COVID-19/Flu A&B. Applicant as listed: Princeton BioMeditech Corp.. Decision date: 2025-11-14.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250588. Device: Access Rubella IgG. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2025-11-17.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K252550. Device: SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx. Applicant as listed: Guangzhou Wondfo Biotech Co., Ltd.. Decision date: 2025-11-18.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K252818. Device: Dexcom Smart Basal. Applicant as listed: Dexcom, Inc.. Decision date: 2025-11-18.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250912. Device: IntelliSep Test. Applicant as listed: Cytovale, Inc.. Decision date: 2025-11-19.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243753. Device: cobas liat Bordetella panel nucleic acid test. Applicant as listed: Roche Molecular Systems, Inc.. Decision date: 2025-11-20.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K253105. Device: HardyDisk AST Cefiderocol 30µg (FDC30). Applicant as listed: Hardy Diagnostics. Decision date: 2025-11-20.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K252762. Device: HALO AP Dx. Applicant as listed: Indica Labs, LLC. Decision date: 2025-11-25.
Source: api.fda.gov · Retrieved 2026-10-22
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.