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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FDA 510(k) index record K200436. Device: Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit. Applicant as listed: Hologic, Inc.. Decision date: 2020-03-23.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K192987. Device: Aina HbA1c Monitoring System 2. Applicant as listed: Jana Care, Inc.. Decision date: 2020-03-26.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193053. Device: Tina-quant Hemoglobin A1cDx Gen.3. Applicant as listed: Roche Diagnostics Operations (Rdo). Decision date: 2020-03-26.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K192240. Device: RAPIDPoint 500e Blood Gas System. Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2020-03-27.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193054. Device: Sectra Digital Pathology Module. Applicant as listed: Sectra AB. Decision date: 2020-03-31.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K200010. Device: FilmArray BCID2 Control Panel M416. Applicant as listed: Maine Molecular Quality Controls, Inc.. Decision date: 2020-04-02.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K192719. Device: Osom Ultra Plus Flu A&B Test Kit. Applicant as listed: SEKISUI Diagnostics, LLC. Decision date: 2020-04-03.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K200199. Device: ADVIA Centaur CA 125II. Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2020-04-06.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K200308. Device: MTS Lefamulin 0.016- 256 µg/mL. Applicant as listed: Liofilchem S. R. 1.. Decision date: 2020-04-06.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K200215. Device: ADVIA Centaur CEA Assay. Applicant as listed: Siemens Healthcare Disgnostics, Inc.. Decision date: 2020-04-13.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193124. Device: Unicel DxH 800 Coulter Cellular Analysis System. Applicant as listed: Beckman Coulter. Decision date: 2020-04-16.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193074. Device: Bevel Up Holder. Applicant as listed: Nsp Tech Pte, Ltd.. Decision date: 2020-04-21.
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.