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 K222141. Device: Safety Blood Collection Needle (Without Needle Holder). Applicant as listed: Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. Decision date: 2022-10-21.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K213804. Device: cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems. Applicant as listed: Roche Molecular Systems, Inc.. Decision date: 2022-10-22.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K221885. Device: 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports. Applicant as listed: 23AndMe, Inc.. Decision date: 2022-10-26.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K213690. Device: Eclipse Blood Collection Set. Applicant as listed: Eclipse Medcorp, LLC. Decision date: 2022-10-26.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K221420. Device: AlphaID At Home Genetic Health Risk Service. Applicant as listed: Progenika Biopharma S.A., A Grifols Company. Decision date: 2022-10-27.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K222601. Device: FilmArray Pneumonia Panel plus. Applicant as listed: Biofire Diagnostics, LLC. Decision date: 2022-10-27.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220949. Device: Architect CMV IgG. Applicant as listed: Abbott Laboratories. Decision date: 2022-10-27.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K212745. Device: ORAcollect®Dx. Applicant as listed: DNA Genotek, Inc.. Decision date: 2022-10-27.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201256. Device: Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge. Applicant as listed: Procise Diagnostics. Decision date: 2022-11-04.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220421. Device: BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System. Applicant as listed: Apex BioTechnology Corp.. Decision date: 2022-11-04.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K202755. Device: Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack. Applicant as listed: Diasorin Molecular, LLC. Decision date: 2022-11-05.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K210346. Device: Sysmex XW-100 Automated Hematology Analyzer. Applicant as listed: Sysmex America, Inc.. Decision date: 2022-11-08.
Source: api.fda.gov · Retrieved 2026-10-29
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.