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 K213936. Device: LIAISON MeMed BV, LIAISON MeMed BV Control Set. Applicant as listed: DiaSorin, Inc.. Decision date: 2022-07-14.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220258. Device: 20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000). Applicant as listed: Avia Vascular. Decision date: 2022-07-14.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K212778. Device: Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075). Applicant as listed: Abbott Molecular, Inc.. Decision date: 2022-07-15.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K203680. Device: BioFire JI Control Panel M420. Applicant as listed: Maine Molecular Quality Controls, Inc.. Decision date: 2022-07-22.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K221460. Device: BioFire COVID-19 Test 2. Applicant as listed: Biofire Defense, LLC. Decision date: 2022-07-25.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K213858. Device: LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus. Applicant as listed: DiaSorin, Inc.. Decision date: 2022-07-26.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K210902. Device: EliA Ro52, EliA Ro60. Applicant as listed: Phadia AB. Decision date: 2022-07-27.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K214122. Device: BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel. Applicant as listed: Becton, Dickinson and Company. Decision date: 2022-07-28.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K212113. Device: MagXtract Collection Tube. Applicant as listed: Magbio Genomics, Inc.. Decision date: 2022-07-28.
Source: api.fda.gov · Retrieved 2026-10-29
FDA 510(k) index record K221259. Device: Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System. Applicant as listed: Dexcom, Inc.. Decision date: 2022-07-29.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K202852. Device: DiviTum TKa. Applicant as listed: Biovica International AB. Decision date: 2022-07-29.
Source: api.fda.gov · Retrieved 2026-10-29
FDA 510(k) index record K212181. Device: ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed. Applicant as listed: Phadia AB. Decision date: 2022-08-03.
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.