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.
Filtrar documentos
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220046. Device: Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11. Applicant as listed: Shenzhen Superbio Technology Co., Ltd.. Decision date: 2022-12-13.
Fuente: api.fda.gov · Consultado el 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223433. Device: Quantra QPlus System. Applicant as listed: Hemosonics, LLC. Decision date: 2022-12-13.
Fuente: api.fda.gov · Consultado el 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220052. Device: Copan FecalSwab Collection, Transport and Preservation System. Applicant as listed: Copan Italia Spa. Decision date: 2022-12-16.
Fuente: api.fda.gov · Consultado el 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K212559. Device: CardioPhase® hsCRP. Applicant as listed: Siemens Healthcare Diagnostics Products GmbH. Decision date: 2022-12-16.
Fuente: api.fda.gov · Consultado el 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K221896. Device: BreathID Hp System. Applicant as listed: Meridian Bioscience Israel , Ltd.. Decision date: 2022-12-19.
Fuente: api.fda.gov · Consultado el 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K221826. Device: BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30). Applicant as listed: Becton, Dickinson and Company. Decision date: 2022-12-21.
Fuente: api.fda.gov · Consultado el 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K222234. Device: GlucoSure ADVANCE Link Blood Glucose Monitoring System. Applicant as listed: Apex BioTechnology Corp.. Decision date: 2022-12-21.
Fuente: api.fda.gov · Consultado el 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K213875. Device: DRI TM Tricyclics Serum Tox Assay. Applicant as listed: Microgenics Corporation. Decision date: 2022-12-21.
Fuente: api.fda.gov · Consultado el 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K211058. Device: Lp(a) Ultra. Applicant as listed: SENTINEL CH. SpA. Decision date: 2022-12-22.
Fuente: api.fda.gov · Consultado el 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K211485. Device: STA- NeoPTimal. Applicant as listed: Diagnostica Stago S.A.S. Decision date: 2022-12-23.
Fuente: api.fda.gov · Consultado el 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223289. Device: Access Vitamin B12. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2022-12-23.
Fuente: api.fda.gov · Consultado el 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K214002. Device: CRYOcheck Chromogenic Factor IX. Applicant as listed: Precision Biologic, Inc.. Decision date: 2022-12-23.
Fuente: api.fda.gov · Consultado el 2026-10-29
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.