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 K241188. Device: Acucy® Influenza A&B Test with the Acucy® 2 System. Applicant as listed: SEKISUI Diagnostics, LLC. Decision date: 2025-04-18.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242170. Device: K-ASSAY CRP (Ver.2). Applicant as listed: Kamiya Biomedical Company, LLC. Decision date: 2025-04-18.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243343. Device: BD CTGCTV2. Applicant as listed: Bd Integrated Diagnostic Solutions/Becton,. Decision date: 2025-04-22.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243570. Device: Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L). Applicant as listed: Siemens Healthcare Diagnostics. Decision date: 2025-04-25.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243406. Device: cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test. Applicant as listed: Roche Molecular Systems, Inc.. Decision date: 2025-04-25.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243400. Device: cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test. Applicant as listed: Roche Molecular Systems, Inc.. Decision date: 2025-04-25.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251024. Device: TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge. Applicant as listed: Haemonetics. Decision date: 2025-04-30.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250907. Device: Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set. Applicant as listed: Sol-Millennium Medical, Inc.. Decision date: 2025-04-30.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250274. Device: ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL). Applicant as listed: Biomerieux S.A.. Decision date: 2025-04-30.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250995. Device: Xpert Xpress CoV-2/Flu/RSV plus. Applicant as listed: Cepheid®. Decision date: 2025-05-01.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K244014. Device: i-STAT CG4+ cartridge with the i-STAT 1 System. Applicant as listed: Abbott Point of Care, Inc.. Decision date: 2025-05-02.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243114. Device: SQA-iOw Sperm Quality Analyzer. Applicant as listed: Medical Electronic Systems , Ltd.. Decision date: 2025-05-02.
Source: api.fda.gov · Retrieved 2026-10-24
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.