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) K203289 — Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit
OtherU.S. Food and Drug Administration (FDA)
FDA 510(k) index record K203289. Device: Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit. Applicant as listed: Gold Standard Diagnostics. Decision date: 2021-03-22.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K203292. Device: Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit. Applicant as listed: Gold Standard Diagnostics. Decision date: 2021-03-22.
Source: api.fda.gov · Retrieved 2026-10-19
FDA 510(k) K202453 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
OtherU.S. Food and Drug Administration (FDA)
FDA 510(k) index record K202453. Device: SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card. Applicant as listed: Safecare Biotech (Hangzhou) Co., Ltd.. Decision date: 2021-03-24.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K202325. Device: EasyPoint Blood Collection Plus. Applicant as listed: Retractable Technologies, Inc.. Decision date: 2021-04-09.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K202136. Device: IDS Cortisol. Applicant as listed: Immunodiagnostic Systems , Ltd.. Decision date: 2021-04-13.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K203364. Device: MDPC-8127. Applicant as listed: Barco N.V.. Decision date: 2021-04-15.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193649. Device: Yumizen C1200 Creatinine PAP. Applicant as listed: HORIBA ABX SAS. Decision date: 2021-05-10.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K211115. Device: A1AT Genotyping Test. Applicant as listed: Progenika Biopharma S.A., A Grifols Company. Decision date: 2021-05-13.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K202423. Device: MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL). Applicant as listed: Beckman Coulter, Inc.. Decision date: 2021-05-18.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193604. Device: Aptiva Celiac Disease IgA Reagent. Applicant as listed: Inova Diagnostics, Inc.. Decision date: 2021-06-16.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K202196. Device: BioFire RP2.1/RP2.1plus Control Panel M441. Applicant as listed: Maine Molecular Quality Controls, Inc.. Decision date: 2021-06-24.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201228. Device: Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair. Applicant as listed: Psychemedics Corporation. Decision date: 2021-06-25.
Source: api.fda.gov · Retrieved 2026-10-19
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.