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 K233688. Device: Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set. Applicant as listed: Quidel Corporation. Decision date: 2023-12-13.
Fuente: api.fda.gov · Consultado el 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232892. Device: Hp Detect Stool Antigen ELISA. Applicant as listed: Biomerica, Inc.. Decision date: 2023-12-15.
Fuente: api.fda.gov · Consultado el 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232095. Device: SeptiCyte RAPID. Applicant as listed: Immunexpress, Inc.. Decision date: 2023-12-15.
Fuente: api.fda.gov · Consultado el 2026-10-27
FDA 510(k) index record K232736. Device: Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test. Applicant as listed: Chemtron Biotech, Inc.. Decision date: 2023-12-20.
Fuente: api.fda.gov · Consultado el 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K230855. Device: BD Vacutainer® Serum Separator (SST) Blood Collection Tubes. Applicant as listed: Becton, Dickinson and Company. Decision date: 2023-12-20.
Fuente: api.fda.gov · Consultado el 2026-10-19
FDA 510(k) K232286 — Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument
OtherU.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232286. Device: Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument. Applicant as listed: Quidel Corporation. Decision date: 2023-12-20.
Fuente: api.fda.gov · Consultado el 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231027. Device: KaiBiLi Extended ViralTrans. Applicant as listed: Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.. Decision date: 2023-12-21.
Fuente: api.fda.gov · Consultado el 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K230887. Device: Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer. Applicant as listed: Sysmex America, Inc.. Decision date: 2023-12-21.
Fuente: api.fda.gov · Consultado el 2026-10-27
FDA 510(k) index record K232881. Device: Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder. Applicant as listed: Jiangsu Kangbao Medical Equipment Co., Ltd.. Decision date: 2023-12-22.
Fuente: api.fda.gov · Consultado el 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K230267. Device: NeuMoDx CT/NG Assay 2.0. Applicant as listed: Neumodx Molecular, Inc.. Decision date: 2023-12-22.
Fuente: api.fda.gov · Consultado el 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K233027. Device: NanoZoomer S360MD Slide scanner system. Applicant as listed: Hamamatsu Photonics K.K.. Decision date: 2023-12-22.
Fuente: api.fda.gov · Consultado el 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K233058. Device: VivaChek Link Plus Blood Glucose Monitoring System. Applicant as listed: Vivachek Biotech (Hangzhou) Co., Ltd.. Decision date: 2023-12-22.
Fuente: api.fda.gov · Consultado el 2026-10-26
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.