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 K232276. Device: Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20. Applicant as listed: Oxoid Limited (Part of Thermo Fisher Scientific). Decision date: 2023-10-06.
Fuente: api.fda.gov · Consultado el 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232775. Device: ID NOW Influenza A & B 2. Applicant as listed: Abbott Diagnostics Scarborough, Inc.. Decision date: 2023-10-10.
Fuente: api.fda.gov · Consultado el 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K230741. Device: Macro & Micro-Test HCG Pregnancy Test Midstream. Applicant as listed: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.. Decision date: 2023-10-13.
Fuente: api.fda.gov · Consultado el 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K230440. Device: Xpert® Xpress CoV-2 plus. Applicant as listed: Cepheid®. Decision date: 2023-10-13.
Fuente: api.fda.gov · Consultado el 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231824. Device: SmartBolus Calculator. Applicant as listed: Insulet Corporation. Decision date: 2023-10-18.
Fuente: api.fda.gov · Consultado el 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231381. Device: Xpert Xpress MVP; GeneXpert Xpress System. Applicant as listed: Cepheid. Decision date: 2023-10-19.
Fuente: api.fda.gov · Consultado el 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K233417. Device: AllTest Fentanyl Urine Test Cassette. Applicant as listed: Hangzhou AllTest Biotech Co., Ltd.. Decision date: 2023-10-26.
Fuente: api.fda.gov · Consultado el 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231214. Device: LIAISON VZV IgG HT, LIAISON Control VZV IgG HT. Applicant as listed: DiaSorin, Inc.. Decision date: 2023-10-27.
Fuente: api.fda.gov · Consultado el 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K230300. Device: i-STAT CG8+ cartridge with the i-STAT 1 System. Applicant as listed: Abbott Point of Care, Inc.. Decision date: 2023-10-27.
Fuente: api.fda.gov · Consultado el 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K213146. Device: Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen. Applicant as listed: Jiangsu Rongye Technology Co., Ltd.. Decision date: 2023-10-27.
Fuente: api.fda.gov · Consultado el 2026-10-27
FDA 510(k) index record K232310. Device: Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml. Applicant as listed: Thermo Fisher Scientific. Decision date: 2023-10-31.
Fuente: api.fda.gov · Consultado el 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K233062. Device: BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx. Applicant as listed: Vivachek Biotech (Hangzhou) Co., Ltd.. Decision date: 2023-11-02.
Fuente: api.fda.gov · Consultado el 2026-10-27
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.