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 K242367. Device: BIOFIRE FILMARRAY Gastrointestinal (GI) Panel. Applicant as listed: Biofire Diagnostics, LLC. Decision date: 2024-11-07.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242802. Device: CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette. Applicant as listed: Hangzhou Clongene Biotech Co., Ltd.. Decision date: 2024-11-08.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242465. Device: Panther Fusion SARS-CoV-2/Flu A/B/RSV assay. Applicant as listed: Hologic, Inc.. Decision date: 2024-11-15.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K221349. Device: XPER Technology PREMIUM Pro Blood Glucose Monitoring System. Applicant as listed: Taidoc Technology Corporation. Decision date: 2024-11-19.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243064. Device: ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test. Applicant as listed: Eterbio, Inc.. Decision date: 2024-11-20.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243405. Device: Xpert vanA. Applicant as listed: Cepheid®. Decision date: 2024-11-21.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K221326. Device: Nova Allegro HbA1c Assay, Nova Allegro Analyzer. Applicant as listed: Nova Biomedical Corporation. Decision date: 2024-11-22.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243345. Device: Aptima BV Assay; Aptima CV/TV Assay. Applicant as listed: Hologic, Inc.. Decision date: 2024-11-25.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242657. Device: The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mL. Applicant as listed: Thermo Fisher Scientific. Decision date: 2024-11-26.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K241628. Device: YO Home Sperm Test. Applicant as listed: Medical Electronic Systems , Ltd.. Decision date: 2024-11-29.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K241871. Device: Philips IntelliSite Pathology Solution. Applicant as listed: Philips Medical Systems Nederland B.V.. Decision date: 2024-12-02.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242685. Device: Atellica® CH Creatinine_3 (Crea3). Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2024-12-04.
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.