Q Retrieval High pH 9.0 (50x)
by biocyc Biotechnologie GmbH & Co. KG 2 variants
Ref AR-002-1000
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 | Number42555978AGRETRIEVAL9Y 04255597800342 | 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- Withdrawn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
- antigen retrieval solution
- Model / Reference
- AR-002-1000
- Primary DI / UDI-DI
- 04255597800342
- Basic UDI-DI
- 42555978AGRETRIEVAL9Y, 42555978AGRETRAR002Z5
- Direct Marketing DI
- 04255597800342
- 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 (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