De Novo DEN150058
- Device
- Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak
- Contact
- elizabeth platt
- De Novo number
- DEN150058
- Product code
- PMN
- Regulation
- 866.3920
- Classification name
- assayed external control material for microbiology nucleic acid amplification (nat) assays
- Decision
- granted (DENG)
- Decision date
- 2016-03-28
- Date received
- 2015-12-16
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Post-NSE
Current FDA Classification#
- Product code
- PMN
- Device name
- Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.3920
- Implant
- N
- Life sustain/support
- N