Na R30165201
by Remel Europe Limited GUDID
Listed (no authorization)
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05056080501048 | Date9 Dec 2016 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — GUDID listing Listed
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Trade Name
- Na
- Generic Name
- Vibrio cholerae culture isolate antigen (multiple serotype) IVD, kit, agglutination
- Model / Reference
- R30165201
- Primary DI / UDI-DI
- 05056080501048
- FDA Product Code
- GSO
- GMDN Term
- Vibrio cholerae culture isolate antigen (multiple serotype) IVD, kit, agglutination
- Device Class
- Class II
- Regulation Number
- 866.3085
- Commercial Distribution
- In Commercial Distribution
Other devices from Remel Europe Limited
Properties
Other properties (11)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Manufacturing Date: No