Elecsys CEA 07027079190
Elecsys CEA 07027079190 is a Class II device made by Roche Diagnostics GmbH, cleared under FDA 510(k) K980887 on 29 Jun 1998 and listed in FDA GUDID since 14 Apr 2017 (UDI-DI 04015630939664), active as of 12 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 | Number04015630939664 | Date14 Apr 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK980887 | Date29 Jun 1998 | StatusActive |
Official records
- AccessGUDID record 04015630939664
- FDA 510(k) database K980887
Across registries
- FDA 510(k) K980887 decided 29 Jun 1998 Active
- FDA GUDID UDI-DI 04015630939664 listed 14 Apr 2017 Listed
Timeline
- Cleared FDA 510(k) K980887
- Listed FDA GUDID 04015630939664
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Elecsys CEA
- Generic name
- Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay
- Model / Ref / Catalog
- 07027079190
- Primary DI / UDI-DI
- 04015630939664
- 510(k) Number
- FDA product code
- DHX
- GMDN term
- Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay
- Device class
- Class II
- Regulation number
- 866.6010
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay.