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 K253528. Device: Atellica IM CA 19-9 II. Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2026-08-10.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K262472. Device: Stelo Glucose Biosensor System. Applicant as listed: Dexcom, Inc.. Decision date: 2026-08-11.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K253985. Device: INNOVANCE® D-Dimer 2.0 (SMN 10873803). Applicant as listed: Siemens Healthcare Diagnostic Products GmbH. Decision date: 2026-08-11.
Source: api.fda.gov · Retrieved 2026-10-20
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K253240. Device: PrecivityAD2 Test. Applicant as listed: C2N Diagnostics, LLC. Decision date: 2026-08-19.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K261686. Device: Elecsys Phospho-Tau (217P) Plasma. Applicant as listed: Roche Diagnostics. Decision date: 2026-08-19.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K262113. Device: HardyDisk AST Tebipenem 10µg (TBP10). Applicant as listed: Hardy Diagnostics. Decision date: 2026-08-20.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K261466. Device: Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM. Applicant as listed: Zeus Scientific. Decision date: 2026-08-21.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K253817. Device: IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La. Applicant as listed: Immunodiagnostics Systems Limited. Decision date: 2026-08-21.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260545. Device: CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring System. Applicant as listed: Ascensia Diabetes Care. Decision date: 2026-08-27.
Source: api.fda.gov · Retrieved 2026-10-20
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260047. Device: cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190). Applicant as listed: Roche Molecular Systems, Inc.. Decision date: 2026-08-28.
Source: api.fda.gov · Retrieved 2026-10-21
FDA 510(k) index record K260045. Device: cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Control Kit for use on the cobas® Liat® System (07454970190). Applicant as listed: Roche Molecular Systems, Inc.. Decision date: 2026-08-28.
Source: api.fda.gov · Retrieved 2026-10-20
FDA 510(k) K262747 — ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0
OtherU.S. Food and Drug Administration (FDA)
FDA 510(k) index record K262747. Device: ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0. Applicant as listed: Abbott Diagnostics Scarborough, Inc.. Decision date: 2026-08-31.
Source: api.fda.gov · Retrieved 2026-10-21
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.