p21WAF1
Ref Z2602RS, Z2602RP, Z2602RT, Z2602RLModel ZR288
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-00840140737226 | 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- Withdrawn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
- ZR288, Z2602RS, Z2602RP, Z2602RT, Z2602RL
- Primary DI / UDI-DI
- 00840140737226, 00840140737240, 00840140737233, 00840140737219
- Basic UDI-DI
- B-00840140737226, B-00840140737240, B-00840140737233, B-00840140737219
- 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