Product code NHT
- Device name
- Assay, Nucleic Acid Amplification, Bacillus Anthracis
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3045
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- An invitro diagnostic device used to presumptively detect the presence or absence of b. Anthracis directly in blood specimens or suspicious culture growth.
- Source
- FDA openFDA device classification dataset