QVR — Multiplex Nucleic Acid Detection System For Biothreat Agents Class II
FDA product code QVR covers "Multiplex Nucleic Acid Detection System For Biothreat Agents", a Class II medical device regulated under 21 CFR 866.4000. Submissions are reviewed by the Immunology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QVR
- Device Class
- Class II
- Regulation Number
- 866.4000
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Immunology
- Implant
- No
Definition
A multiplex nucleic acid detection system for biothreat agents is a qualitative in vitro diagnostic test for detection and identification of nucleic acids from biothreat pathogens in human clinical specimens