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 K231013. Device: DNA/RNA Shield SafeCollect Saliva Collection kit. Applicant as listed: Zymo Research. Decision date: 2023-09-28.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K213403. Device: Aptiva CTD Essential Reagent. Applicant as listed: Inova Diagnostics, Inc.. Decision date: 2023-09-29.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K212769. Device: DYNEX SmartPLEX MMRV IgG Assay Kit. Applicant as listed: Dynex Technologies, Inc.. Decision date: 2023-09-29.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K221508. Device: AnemoCheck Home. Applicant as listed: Sanguina, Inc.. Decision date: 2023-09-29.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K221900. Device: Stat Profile Prime Plus Analyzer System. Applicant as listed: Nova Biomedical Corporation. Decision date: 2023-09-29.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220458. Device: UltraFlo-R Push Button Blood Collection Set. Applicant as listed: Innovative Medical Technologies, Inc.. Decision date: 2023-09-29.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223085. Device: Miris Human Milk Analyzer (HMA). Applicant as listed: Miris AB. Decision date: 2023-09-29.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K221359. Device: ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM. Applicant as listed: Instrumentation Laboratory CO. Decision date: 2023-09-29.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K221890. Device: Elecsys Tg II. Applicant as listed: Roche Diagnostics. Decision date: 2023-09-30.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232722. Device: endo.digital Platform. Applicant as listed: DreaMed Diabetes, Ltd.. Decision date: 2023-10-03.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232395. Device: ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD. Applicant as listed: Biomérieux. Decision date: 2023-10-05.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220451. Device: Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT. Applicant as listed: Randox Laboratories Limited. Decision date: 2023-10-05.
Source: api.fda.gov · Retrieved 2026-10-27
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.