Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled 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 14, 2026, FDA's public records list OpGen and its 2 subsidiaries with 23 510(k) clearances and 6 device recalls. The most recent is a 510(k) clearance dated Sep 30, 2021: Acuitas AMR Gene Panel.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, OpGen and its 2 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 30, 2021 | Acuitas AMR Gene PanelK191288 · PMY | 510(k) clearances |
| Dec 20, 2019 | Unyvero LRT BAL ApplicationK191967 · QBH | 510(k) clearances |
| Apr 3, 2018 | Curetis Unyvero LRT ApplicationDEN170047 · QBH | 510(k) clearances |
| Oct 10, 2014 | MECA XPRESSFISHK140619 · MYI | 510(k) clearances |
| Dec 11, 2013 | AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number: QFGNRBC1-25 Gram-NClass III · Kits incompatible with certain fluorescence microscope light sources | Device recalls |
| Jul 21, 2013 | GRAM-NEGATIVE QUICKFISH BCK123418 · JSS | 510(k) clearances |
| Jan 7, 2013 | ENTEROCOCCUS QUICKFISH BCK121991 · OAH | 510(k) clearances |
| Apr 3, 2012 | STAPHYLOCOCCUS QUICKFISH BCK113371 · NXX | 510(k) clearances |
| Dec 16, 2010 | GNR TRAFFIC LIGHT PNA FISHK101558 · JSS | 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
