Product code PMN
- Device name
- Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3920
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use.
- Source
- FDA openFDA device classification dataset
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