GNR — Antisera, Neutralization, Influenza Virus A, B, C Class I
FDA product code GNR covers "Antisera, Neutralization, Influenza Virus A, B, C", a Class I medical device regulated under 21 CFR 866.3330. 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
- GNR
- Device Class
- Class I
- Regulation Number
- 866.3330
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K984596 | zymetx | VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES | March 4, 1999 |