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 K251563. Device: WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test. Applicant as listed: Wondfo USA Co, Ltd.. Decision date: 2025-08-20.
Fuente: api.fda.gov · Consultado el 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251580. Device: MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD). Applicant as listed: Liofilchem s.r.l.. Decision date: 2025-08-20.
Fuente: api.fda.gov · Consultado el 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243804. Device: MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan). Applicant as listed: Beckman Coulter, Inc.. Decision date: 2025-08-20.
Fuente: api.fda.gov · Consultado el 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243965. Device: Origin. Applicant as listed: Nerv Technology Inc. (D.B.A.) Fluidai Medical. Decision date: 2025-08-21.
Fuente: api.fda.gov · Consultado el 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251604. Device: CareSuperb COVID-19/Flu A&B Antigen Combo Home Test. Applicant as listed: Access Bio, Inc.. Decision date: 2025-08-22.
Fuente: api.fda.gov · Consultado el 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251440. Device: CRYOcheck Chromogenic Factor VIII. Applicant as listed: Precision Biologic, Inc.. Decision date: 2025-08-25.
Fuente: api.fda.gov · Consultado el 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251404. Device: Quantra QStat Cartridge. Applicant as listed: Hemosonics, LLC. Decision date: 2025-08-25.
Fuente: api.fda.gov · Consultado el 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K252118. Device: CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup. Applicant as listed: Hangzhou Clongene Biotech Co., Ltd.. Decision date: 2025-08-27.
Fuente: api.fda.gov · Consultado el 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250080. Device: QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini. Applicant as listed: QIAGEN GmbH. Decision date: 2025-08-27.
Fuente: api.fda.gov · Consultado el 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K252014. Device: The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL. Applicant as listed: Thermo Fisher Scientific. Decision date: 2025-08-28.
Fuente: api.fda.gov · Consultado el 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250003. Device: GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005). Applicant as listed: Geneseeq Technology, Inc.. Decision date: 2025-08-29.
Fuente: api.fda.gov · Consultado el 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250575. Device: The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL. Applicant as listed: Thermo Fisher Scientific. Decision date: 2025-09-05.
Fuente: api.fda.gov · Consultado el 2026-10-23
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.