p53
by Zeta Corporation 5 variants
Ref Z2029MT, Z2029ML, Z2466RS, Z2466RTModel DO-7, ZR153
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-00840140711325 | Date1 Apr 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Model / Reference
- DO-7, Z2029MT, Z2029ML, ZR153, Z2466RS, Z2466RT
- Primary DI / UDI-DI
- 00840140711325, 00840140711301, 00840140730678, 00840140730685
- Basic UDI-DI
- B-00840140711325, B-00840140711301, B-00840140730678, B-00840140730685
- EMDN Code
- W01030709 Primary antisera for immunohistology
- Device Class
- Class IVD General
- EU market of registration
- Denmark
Manufacturer details
- EUDAMED SRN
- US-MF-000008650
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Zeta Corporation
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No