ImmunoCard C. difficile GDH 716050
ImmunoCard C. difficile GDH 716050 is a Class I device made by Meridian Bioscience Inc., cleared under FDA 510(k) K112048 on 16 Dec 2011 and listed in FDA GUDID since 11 Aug 2020 (UDI-DI 00840733101793), active as of 8 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00840733101793 | Date11 Aug 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK112048 | Date16 Dec 2011 | StatusActive |
Official records
- AccessGUDID record 00840733101793
- FDA 510(k) database K112048
Across registries
- FDA 510(k) K112048 decided 16 Dec 2011 Active
- FDA GUDID UDI-DI 00840733101793 listed 11 Aug 2020 Listed
Timeline
- Cleared FDA 510(k) K112048
- Listed FDA GUDID 00840733101793
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ImmunoCard C. difficile GDH
- Generic name
- Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)
- Model / Ref / Catalog
- 716050
- Primary DI / UDI-DI
- 00840733101793
- 510(k) Number
- FDA product code
- MCB
- GMDN term
- Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)
- Device class
- Class I
- Regulation number
- 866.2660
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA).