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De Novo DEN130013
- Device
- VITEK MS
- Contact
- nancy weaver
- De Novo number
- DEN130013
- Product code
- PEX
- Regulation
- 866.3361
- Classification name
- system, mass spectrometry, maldi tof, microorganism identification, cultured isolates
- Decision
- granted (DENG)
- Decision date
- 2013-08-21
- Date received
- 2013-01-02
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Direct
Current FDA Classification#
- Product code
- PEX
- Device name
- System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.3361
- Implant
- N
- Life sustain/support
- N