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 K253658. Device: STA Satellite Max®. Applicant as listed: Diagnostica Stago, Inc.. Decision date: 2026-04-27.
Source: api.fda.gov · Retrieved 2026-10-20
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260065. Device: SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx. Applicant as listed: Guangzhou Wondfo Biotech Co., Ltd.. Decision date: 2026-04-28.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260342. Device: AllTest Strep A Rapid Test. Applicant as listed: Hangzhou AllTest Biotech Co., Ltd.. Decision date: 2026-04-30.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K252475. Device: ABL90 FLEX PLUS System. Applicant as listed: Radiometer Medicals Aps. Decision date: 2026-05-01.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K254139. Device: BioCode® Respiratory Pathogen Panel (RPP). Applicant as listed: Applied BioCode, Inc.. Decision date: 2026-05-01.
Source: api.fda.gov · Retrieved 2026-10-20
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K254115. Device: ArteraAI Breast. Applicant as listed: Artera, Inc.. Decision date: 2026-05-04.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250814. Device: Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB. Applicant as listed: Zeus Scientific. Decision date: 2026-05-08.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260842. Device: HardyDisk AST Gepotidacin 10µg (GEP10). Applicant as listed: Hardy Diagnostics. Decision date: 2026-05-11.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260235. Device: CellDx-Tissue. Applicant as listed: Datar Cancer Genetics Private Limited. Decision date: 2026-05-12.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K253756. Device: cobas liat CT/NG nucleic acid test. Applicant as listed: Roche Molecular Systems, Inc.. Decision date: 2026-05-15.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K253759. Device: cobas liat CT/NG/MG nucleic acid test. Applicant as listed: Roche Molecular Systems, Inc.. Decision date: 2026-05-15.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260577. Device: FilmArray TF Control Panel M527. Applicant as listed: Maine Molecular Quality Controls, Inc.. Decision date: 2026-05-19.
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.