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 K213953. Device: BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes. Applicant as listed: Becton, Dickinson and Company. Decision date: 2023-07-17.
Fuente: api.fda.gov · Consultado el 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K210801. Device: AXINON® LDL-p Test System. Applicant as listed: Numares AG. Decision date: 2023-07-19.
Fuente: api.fda.gov · Consultado el 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220977. Device: ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer. Applicant as listed: Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.. Decision date: 2023-07-20.
Fuente: api.fda.gov · Consultado el 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223637. Device: Elecsys proBNP II, Elecsys proBNP II STAT. Applicant as listed: Roche Diagnostics. Decision date: 2023-07-21.
Fuente: api.fda.gov · Consultado el 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223317. Device: Alkaline Phosphatase2. Applicant as listed: Abbott Ireland Diagnostics Division. Decision date: 2023-07-21.
Fuente: api.fda.gov · Consultado el 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K221605. Device: Emit® II Plus Buprenorphine Assay. Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2023-07-25.
Fuente: api.fda.gov · Consultado el 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K222438. Device: A-LYTE® Integrated Multisensor (IMT Na K Cl). Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2023-07-25.
Fuente: api.fda.gov · Consultado el 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223591. Device: cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System. Applicant as listed: Roche Molecular Systems, Inc.. Decision date: 2023-07-27.
Fuente: api.fda.gov · Consultado el 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231221. Device: MDx-Chex for BC-GP. Applicant as listed: Streck. Decision date: 2023-07-27.
Fuente: api.fda.gov · Consultado el 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231223. Device: MDx-Chex for BC-GN. Applicant as listed: Streck. Decision date: 2023-07-27.
Fuente: api.fda.gov · Consultado el 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223781. Device: Quantisal II Oral Fluid Collection Device. Applicant as listed: Immunalysis Corporation. Decision date: 2023-07-28.
Fuente: api.fda.gov · Consultado el 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231698. Device: AllTest Fentanyl Rapid Test (Urine). Applicant as listed: Hangzhou AllTest Biotech Co., Ltd.. Decision date: 2023-07-31.
Fuente: api.fda.gov · Consultado el 2026-10-28
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.