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.
Filtrar documentos
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250324. Device: QIAstat-Dx GI Panel 2 Mini B. Applicant as listed: QIAGEN GmbH. Decision date: 2025-02-28.
Fuente: api.fda.gov · Consultado el 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242190. Device: Access Cortisol; DxC 500i Clinical Analyzer. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2025-03-05.
Fuente: api.fda.gov · Consultado el 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243871. Device: Philips IntelliSite Pathology Solution 5.1. Applicant as listed: Philips Medical Systems Nederland B.V.. Decision date: 2025-03-06.
Fuente: api.fda.gov · Consultado el 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250344. Device: BD Phoenix Automated Microbiology System. Applicant as listed: Becton, Dickinson and Company. Decision date: 2025-03-06.
Fuente: api.fda.gov · Consultado el 2026-10-24
FDA 510(k) index record K243931. Device: CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4). Applicant as listed: Centers for Disease Control and Prevention. Decision date: 2025-03-14.
Fuente: api.fda.gov · Consultado el 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K234012. Device: VITEK COMPACT PRO. Applicant as listed: bioMerieux, Inc.. Decision date: 2025-03-14.
Fuente: api.fda.gov · Consultado el 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242244. Device: Viewer+. Applicant as listed: Lumea, Inc.. Decision date: 2025-03-14.
Fuente: api.fda.gov · Consultado el 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240287. Device: LYHER® Oral fluid Multi-Drug Test Kit (Cube). Applicant as listed: Hangzhou Laihe Biotech Co., Ltd.. Decision date: 2025-03-18.
Fuente: api.fda.gov · Consultado el 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243922. Device: Revogene. Applicant as listed: Meridian Bioscience, Inc.. Decision date: 2025-03-20.
Fuente: api.fda.gov · Consultado el 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250106. Device: Signos Glucose Monitoring System. Applicant as listed: Signos, Inc.. Decision date: 2025-03-21.
Fuente: api.fda.gov · Consultado el 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243649. Device: BD Vacutainer® Multiple Sample Luer Adapter. Applicant as listed: Becton, Dickinson and Company. Decision date: 2025-03-21.
Fuente: api.fda.gov · Consultado el 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250513. Device: IntelliSep Test (CV-ICG-048). Applicant as listed: Cytovale, Inc.. Decision date: 2025-03-21.
Fuente: api.fda.gov · Consultado el 2026-10-24
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.