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 K252619. Device: QSCHECK UISACR. Applicant as listed: Qstag, Inc.. Decision date: 2026-02-20.
Fuente: api.fda.gov · Consultado el 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251998. Device: Atellica CH Diazo Total Bilirubin (D_TBil). Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2026-02-27.
Fuente: api.fda.gov · Consultado el 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K254032. Device: QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B. Applicant as listed: QIAGEN GmbH. Decision date: 2026-03-09.
Fuente: api.fda.gov · Consultado el 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260355. Device: Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup. Applicant as listed: WEBEST Biotech,, LLC. Decision date: 2026-03-09.
Fuente: api.fda.gov · Consultado el 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K254059. Device: Access anti-HBc IgM. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2026-03-13.
Fuente: api.fda.gov · Consultado el 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251916. Device: GenBody COVID-19 Ag Home Test. Applicant as listed: Genbody.Inc.. Decision date: 2026-03-13.
Fuente: api.fda.gov · Consultado el 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K252040. Device: BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes. Applicant as listed: Becton, Dickinson and Company. Decision date: 2026-03-13.
Fuente: api.fda.gov · Consultado el 2026-10-20
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K253705. Device: Healgen® Accurate Oral Fluid Drug Test. Applicant as listed: Healgen Scientific,, LLC. Decision date: 2026-03-16.
Fuente: api.fda.gov · Consultado el 2026-10-20
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K254167. Device: MDx-Chex for BCY. Applicant as listed: Streck, LLC. Decision date: 2026-03-17.
Fuente: api.fda.gov · Consultado el 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260551. Device: HemosIL Factor V Leiden (APC Resistance V). Applicant as listed: Instrumentation Laboratory (IL) Co.. Decision date: 2026-03-20.
Fuente: api.fda.gov · Consultado el 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K254166. Device: MDx-Chex for BCN. Applicant as listed: Streck. Decision date: 2026-03-23.
Fuente: api.fda.gov · Consultado el 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K252169. Device: Access BNP II. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2026-03-24.
Fuente: api.fda.gov · Consultado el 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.