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 K243144. Device: X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application. Applicant as listed: Scopio Labs , Ltd.. Decision date: 2025-06-27.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250990. Device: The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL. Applicant as listed: Thermo Fisher Scientific. Decision date: 2025-06-30.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243485. Device: Alinity m CMV. Applicant as listed: Abbott Molecular, Inc.. Decision date: 2025-07-01.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243207. Device: BD Vacutainer® Eclipse Blood Collection Needle. Applicant as listed: Becton, Dickinson and Company. Decision date: 2025-07-03.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250398. Device: Innovita Flu A/B Antigen Rapid Test. Applicant as listed: Innovita (Tangshan) Biological Technology Co., Ltd.. Decision date: 2025-07-03.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243500. Device: ARCHITECT iGentamicin. Applicant as listed: Abbott Laboratories. Decision date: 2025-07-09.
Source: api.fda.gov · Retrieved 2026-10-23
FDA 510(k) index record K243274. Device: CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4). Applicant as listed: Centers for Disease Control and Prevention. Decision date: 2025-07-11.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251053. Device: Shinetell PlusTM Digital Early Pregnancy Test. Applicant as listed: Hangzhou AllTest Biotech Co., Ltd.. Decision date: 2025-07-15.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242505. Device: Elecsys Cortisol III. Applicant as listed: Roche Diagnostics. Decision date: 2025-07-17.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250084. Device: MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL). Applicant as listed: Beckman Coulter, Inc.. Decision date: 2025-07-18.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251564. Device: microINR System. Applicant as listed: Iline Microsystems, S.L.. Decision date: 2025-07-21.
Source: api.fda.gov · Retrieved 2026-10-23
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251968. Device: HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL. Applicant as listed: Instrumentation Laboratory (IL) Co.. Decision date: 2025-07-24.
Source: api.fda.gov · Retrieved 2026-10-23
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.