Q Diluent for IHC w/o Green
by biocyc Biotechnologie GmbH & Co. KG
Ref AD-002-0500
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number42555978DILUENTYE 04255597800380 | Date12 Sep 2023 | 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- Withdrawn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/IVDR Active
Specification
- Device Name
- antibody diluent
- Model / Reference
- AD-002-0500
- Primary DI / UDI-DI
- 04255597800380
- Basic UDI-DI
- 42555978DILUENTYE, 42555978DILUENTAD0022U
- Direct Marketing DI
- 04255597800380
- EMDN Code
- W01030799 Histology / cytology reagents - other
- Device Class
- Class A
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000031533
Other devices from biocyc Biotechnologie GmbH & Co. KG
Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No