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 K252102. Device: Alinity m HCV. Applicant as listed: Abbott Molecular, Inc.. Decision date: 2025-09-25.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251868. Device: Panther Fusion GI Bacterial Assay. Applicant as listed: Hologic. Decision date: 2025-09-25.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251812. Device: Steripath® Flow Blood Collection System. Applicant as listed: Magnolia Medical Technologies. Decision date: 2025-09-25.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251993. Device: Panther Fusion GI Expanded Bacterial Assay. Applicant as listed: Hologic, Inc.. Decision date: 2025-09-25.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250050. Device: miDiagnostics HSV-1&2 CSF Test. Applicant as listed: Midiagnostics NV. Decision date: 2025-09-30.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251501. Device: Visby Medical Men's Sexual Health Test. Applicant as listed: Visby Medical, Inc.. Decision date: 2025-10-01.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K252114. Device: MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL. Applicant as listed: Liofilchem s.r.l.. Decision date: 2025-10-02.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250073. Device: Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01. Applicant as listed: Tosoh Bioscience, Inc.. Decision date: 2025-10-03.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K252163. Device: Elecsys Phospho-Tau (181P) Plasma. Applicant as listed: Roche Diagnostics. Decision date: 2025-10-08.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K252867. Device: VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup. Applicant as listed: Advin Biotech, Inc.. Decision date: 2025-10-09.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250249. Device: Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System. Applicant as listed: Gold Standard Diagnostics, LLC. Decision date: 2025-10-10.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250085. Device: On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System. Applicant as listed: ACON Laboratories, Inc.. Decision date: 2025-10-10.
Source: api.fda.gov · Retrieved 2026-10-19
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.