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) K233986 — BD Phoenix Automated Microbiology System - GN Ciprofloxacin (0.01564 µg/mL)
OtherU.S. Food and Drug Administration (FDA)
FDA 510(k) index record K233986. Device: BD Phoenix Automated Microbiology System - GN Ciprofloxacin (0.01564 µg/mL). Applicant as listed: Becton, Dickinson and Company. Decision date: 2024-03-15.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K230802. Device: Xprecia Prime Coagulation System. Applicant as listed: Universal Biosensors Pty, Ltd.. Decision date: 2024-03-15.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231843. Device: ARX Viral Transport Media Collection and Transport System. Applicant as listed: Arx Sciences, Inc.. Decision date: 2024-03-19.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231974. Device: PATHFAST®hs-cTnI-II. Applicant as listed: Phc Corporation. Decision date: 2024-03-20.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K234052. Device: Access Ferritin. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2024-03-20.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K234006. Device: AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test. Applicant as listed: Allsource Screening Solutions. Decision date: 2024-03-21.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231795. Device: QuickVue COVID-19 Test. Applicant as listed: Quidel Corporation. Decision date: 2024-03-22.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231927. Device: Elecsys PTH , Elecsys PTH STAT. Applicant as listed: Roche Diagnostics. Decision date: 2024-03-22.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231806. Device: Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5. Applicant as listed: Oxoid Limited (Part of Thermo Fisher Scientific). Decision date: 2024-03-22.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232954. Device: BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel. Applicant as listed: Biofire Diagnostics, LLC. Decision date: 2024-03-26.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K233611. Device: SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738). Applicant as listed: Maine Molecular Quality Controls, Inc.. Decision date: 2024-03-26.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240045. Device: QStat Cartridge. Applicant as listed: Hemosonics, LLC. Decision date: 2024-03-27.
Source: api.fda.gov · Retrieved 2026-10-26
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.