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.
Filter documents
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K191562. Device: Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor. Applicant as listed: HORIBA ABX SAS. Decision date: 2020-03-06.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K192815. Device: Elecsys BRAHMS PCT. Applicant as listed: Roche Diagnostics. Decision date: 2020-03-09.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K200370. Device: CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit. Applicant as listed: Centers for Disease Control and Prevention. Decision date: 2020-03-10.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K200363. Device: Quidel Triage® TOX Drug Screen, 94600. Applicant as listed: Quidel Cardiovascular, Inc.. Decision date: 2020-03-11.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K191638. Device: Pointe Scientific Cocaine Metabolite Enzyme Immunoassay. Applicant as listed: Medtest DX. Decision date: 2020-03-12.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193538. Device: Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/ml. Applicant as listed: Thermo Fisher Scientific. Decision date: 2020-03-12.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K192817. Device: Curian HpSA, Curian Analyzer. Applicant as listed: Meridian Bioscience, Inc.. Decision date: 2020-03-13.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K190495. Device: Transferrin. Applicant as listed: Biosystems S.A.. Decision date: 2020-03-16.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193519. Device: BioFire Blood Culture Identification 2 (BCID2) Panel. Applicant as listed: Biofire Diagnostics, LLC. Decision date: 2020-03-18.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193536. Device: MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL). Applicant as listed: Beckman Coulter, Inc.. Decision date: 2020-03-18.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K191657. Device: Bioland Blood Glucose Monitoring System. Applicant as listed: Bioland Technology, Ltd.. Decision date: 2020-03-20.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K200180. Device: MTS Omadacycline 0.002 - 32 ug/mL. Applicant as listed: Liofilchem s.r.l.. Decision date: 2020-03-20.
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.