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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FDA 510(k) index record K220321. Device: Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) Tigris. Applicant as listed: Hologic, Inc.. Decision date: 2022-06-03.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K221160. Device: Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System. Applicant as listed: Cepheid. Decision date: 2022-06-07.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K203757. Device: Elecsys AMH. Applicant as listed: Roche Diagnostics. Decision date: 2022-06-10.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K213626. Device: VITROS AFP. Applicant as listed: Ortho Clinical Diagnostics. Decision date: 2022-06-15.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201037. Device: FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System. Applicant as listed: Taidoc Technology Corporation. Decision date: 2022-06-16.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220494. Device: BreathID Hp Lab System, BreathID Smart System. Applicant as listed: Meridian Bioscience Israel , Ltd.. Decision date: 2022-06-23.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220801. Device: ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2. Applicant as listed: Abbott Diagnostics Scarborough, Inc.. Decision date: 2022-06-24.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K203597. Device: Cholesterol2. Applicant as listed: Abbott Ireland Diagnostics Division. Decision date: 2022-06-30.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K212418. Device: hCG One Step Pregnancy Test. Applicant as listed: Healstone Biotech, Inc.. Decision date: 2022-06-30.
Source: api.fda.gov · Retrieved 2026-10-30
FDA 510(k) K213822 — cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System
OtherU.S. Food and Drug Administration (FDA)
FDA 510(k) index record K213822. Device: cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System. Applicant as listed: Roche Molecular Systems, Inc.. Decision date: 2022-07-06.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201440. Device: ROTEM sigma Thromboelastometry System. Applicant as listed: Tem Innovations GmbH. Decision date: 2022-07-08.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K210793. Device: VIDAS NEPHROCHECK. Applicant as listed: Biomérieux SA. Decision date: 2022-07-08.
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.