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., part of RocheLabelled 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. See the Roche group view.
As of Nov 13, 2026, FDA's public records list GenMark Diagnostics, Inc. with 9 510(k) clearances. The most recent is a 510(k) clearance dated Oct 30, 2026: cobas eplex respiratory pathogen panel 3.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Oct 30, 2026 | cobas eplex respiratory pathogen panel 3K262938 · QOF | 510(k) clearances |
| Apr 27, 2022 | ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelK213236 · PEN | 510(k) clearances |
| Apr 12, 2019 | ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelK182619 · PEN | 510(k) clearances |
| Dec 21, 2018 | ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) PanelK182690 · PEO | 510(k) clearances |
| Dec 20, 2018 | ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) PanelK181663 · PAM | 510(k) clearances |
| Jun 9, 2017 | ePlex InstrumentK163652 · NSU | 510(k) clearances |
| Jun 9, 2017 | ePlex Respiratory Pathogen PanelK163636 · OCC | 510(k) clearances |
| May 26, 2016 | eSensor Warfarin Sensitivity Saliva TestK152612 · ODW | 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
