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De Novo DEN130032
- Device
- XPERT MTB/RIF ASSAY
- Contact
- kerry j flom
- De Novo number
- DEN130032
- Product code
- PEU
- Regulation
- 866.3373
- Classification name
- system, nucleic acid-based, mycobacterium tuberculosis complex, resistance marker, direct specimen
- Decision
- granted (DENG)
- Decision date
- 2013-07-25
- Date received
- 2013-06-11
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Direct
Current FDA Classification#
- Product code
- PEU
- Device name
- System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.3373
- Implant
- N
- Life sustain/support
- N