2 devices · 2 companies · 2013
Product code PEX: System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
2 devices under product code PEX, 2013, from 2 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (0 of 2 here), the regulation, and MAUDE report counts by product code.
System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates. 21 CFR 866.3361, Class II. A mass spectrometer system using matrix-assisted laser desorption/ ionization - time of flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens. MAUDE held 431 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| MALDI BIOTYPER CAK130831 · 510(k) | BRUKER DALTONICS, INC | Microbiology | database entry | |
| VITEK MSDEN130013 · De Novo | BIOMERIEUX, INC. | Microbiology | database entry |
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