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 K231316. Device: Aptima Trichomonas vaginalis Assay. Applicant as listed: Hologic, Inc.. Decision date: 2023-11-06.
Fuente: api.fda.gov · Consultado el 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231752. Device: ARK Hydrocodone Assay. Applicant as listed: Ark Diagnostics, Inc.. Decision date: 2023-11-09.
Fuente: api.fda.gov · Consultado el 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K230828. Device: Flowflex COVID-19 Antigen Home Test. Applicant as listed: ACON Laboratories, Inc.. Decision date: 2023-11-09.
Fuente: api.fda.gov · Consultado el 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K230878. Device: QScout Lab; QScout RLD. Applicant as listed: Ad Astra Diagnostics, Inc.. Decision date: 2023-11-14.
Fuente: api.fda.gov · Consultado el 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232092. Device: Great Basin Toxigenic C. difficile Direct Test (CDF2). Applicant as listed: Vela Operations USA. Decision date: 2023-11-14.
Fuente: api.fda.gov · Consultado el 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K230451. Device: Aptima® Chlamydia trachomatis Assay. Applicant as listed: Hologic, Inc.. Decision date: 2023-11-16.
Fuente: api.fda.gov · Consultado el 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231020. Device: Alinity c Tricyclic Antidepressants Reagent Kit. Applicant as listed: Microgenics Corporation. Decision date: 2023-11-17.
Fuente: api.fda.gov · Consultado el 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232545. Device: The SensiTox B. anthracis Toxin Test. Applicant as listed: First Light Diagnostics, Inc.. Decision date: 2023-11-20.
Fuente: api.fda.gov · Consultado el 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232898. Device: Quantisal Oral Fluid Collection Device. Applicant as listed: Immunalysis Corporation. Decision date: 2023-11-21.
Fuente: api.fda.gov · Consultado el 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232600. Device: DxFLEX Flow Cytometer; ClearLLab 10C Panels. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2023-11-22.
Fuente: api.fda.gov · Consultado el 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K230493. Device: BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube. Applicant as listed: Becton, Dickinson and Company. Decision date: 2023-11-27.
Fuente: api.fda.gov · Consultado el 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232624. Device: CardioPhase® hsCRP. Applicant as listed: Siemens Healthcare Diagnostic Products GmbH. Decision date: 2023-11-27.
Fuente: api.fda.gov · Consultado el 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.