Podoplanin (QR048)
by biocyc Biotechnologie GmbH & Co. KG 2 variants
Ref P-P016-30, C-P016-01, P-P016-70, C-P016-10, C-P016-025, C-P016-05
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-P-P016-30HA | Date6 Nov 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- Withdrawn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/IVDD Active
Specification
- Device Name
- antibody
- Model / Reference
- P-P016-30, C-P016-01, P-P016-70, C-P016-10, C-P016-025, C-P016-05
- Primary DI / UDI-DI
- D-P-P016-30HA, D-C-P016-017Q, D-P-P016-70HN, D-C-P016-107R, D-C-P016-025RH, D-C-P016-057Y
- Basic UDI-DI
- B-P-P016-30HA, B-C-P016-017Q, B-P-P016-70HN, B-C-P016-107R, B-C-P016-025RH, B-C-P016-057Y
- EMDN Code
- W01030709 Primary antisera for immunohistology
- Device Class
- Class IVD General
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000031533
Other devices from biocyc Biotechnologie GmbH & Co. KG
Properties
Other properties (6)
- Sterile: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No