PIQ — Reagents For Detection Of Norovirus Nucleic Acid Class II
FDA product code PIQ covers "Reagents For Detection Of Norovirus Nucleic Acid", a Class II medical device regulated under 21 CFR 866.3990. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PIQ
- Device Class
- Class II
- Regulation Number
- 866.3990
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
Qualitative in vitro diagnostic test for the rapid detection and differentiation of norovirus genogroup I and genogroup II from specimens e.g., stool collected from individuals with symptoms of acute gastroenteritis.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K171511 | r-biopharm | RIDA GENE Norovirus GI/GII | August 21, 2017 |