Home › Device types › PEX
System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
FDA product code PEX · Class 2 · Microbiology
33
Registered devices
431
Adverse events
3
Recalls
5
510(k) clearances
Devices with this code
VITEK®MS — BIOMERIEUX SAVITEK® MS — BIOMERIEUX , INC.VITEK® MS CHCA — BIOMERIEUX SAUS IVD 48 Spot Target — Bruker Daltonik GmbHMALDI Biotyper sirius one CA System — Bruker Daltonik GmbHMALDI Biotyper - smart CA — Bruker Scientific LLCUS IVD-Bruker Bacterial Test Standard, 5 Tubes — Bruker Daltonik GmbHMBT Sepsityper Kit US IVD — Bruker Daltonik GmbHMALDI Biotyper CA System — Bruker Daltonik GmbHMBT-CA System BD — Bruker Daltonik GmbHVITEK® MS knowledge base v3.3 — BIOMERIEUX SAUS IVD-Bruker Bacterial Test Standard, 5 Tubes — Bruker Scientific LLCMALDI Biotyper CA System — Bruker Scientific LLCVITEK® MS MYCOBACTERIUM/NOCARDIA KIT — BIOMERIEUX SAVITEK® MS MOULD KIT — BIOMERIEUX SAUS IVD-HCCA Matrix, Portioned 10 Tubes — Bruker Scientific LLCVITEK® MS-DS — BIOMERIEUX SAUS IVD-HCCA Matrix, Portioned 10 Tubes — Bruker Daltonik GmbHUS IVD 48 Spot Target — Bruker Scientific LLCMALDI Biotyper - smart CA — Bruker Daltonik GmbHMBT-CA System BD — Bruker Scientific LLCUS IVD-HCCA Matrix, Portioned 10 Tubes/7.5mg each — Bruker Daltonik GmbHMBT Biotarget 96 US IVD — Bruker Daltonik GmbHMALDI Biotyper sirius CA System — Bruker Daltonik GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
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