Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Vital Diagnostics (Manufacturing) Pty LtdLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Vital Diagnostics, Inc. with 2 device recalls and 1 510(k) clearance. The most recent is a device recall dated Aug 29, 2013: Consult Diagnostics¿ Eon Calcium Reagent For In-Vitro Diagnostic Use PN: 1429 For the ….
| Aug 29, 2013 | Consult Diagnostics¿ Eon Calcium Reagent For In-Vitro Diagnostic Use PN: 1429 For the quantitative measurement of calcium in plasma and seClass II · High positive calcium bias on plasma sample versus results on serum | Device recalls |
| Aug 29, 2013 | Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. PN 55285 For the quantitative measurement of calcium in plasma and seClass II · High positive calcium bias on plasma sample versus results on serum | Device recalls |
| Jul 27, 2012 | EON CHOLESTEROL REAGENTK120202 · CHH | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built