Data / Medical devices / System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates (PEX): 3 FDA-registered makers in 2 countries
3 establishments in 2 countries are registered with the FDA to make System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates (product code PEX, Class 2, 21 CFR 866.3361). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 5 510(k) clearances under this code, the latest on July 26, 2017, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PEX
- Device class
- 2
- Regulation
- 866.3361
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| Germany | 2 |
| France | 1 |
Makers of System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Bruker Daltonics | Bremen, Germany | Manufacturer, Repackager or relabeler | 3 | July 26, 2017 | 0 | 0 | 0 | api.fda.gov |
| Biomerieux SA | LA BALME LES GROTTES Isere, France | Manufacturer, Specification developer | 2 | July 22, 2017 | 0 | 0 | 0 | api.fda.gov |
| InVivo BioTech Services GmbH | Berlin, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 26, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.