Toxoplasma gondii IgA
by Gold Standard Diagnostics Frankfurt GmbH
Ref 30113625
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-+ENTI301136250H +ENTI301136250H | Date8 Jul 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Device Name
- Toxoplasma gondii IgA
- Model / Reference
- 30113625
- Primary DI / UDI-DI
- +ENTI301136250H
- Basic UDI-DI
- B-+ENTI301136250H
- EMDN Code
- W0105050199 Toxoplasma reagents - other
- Device Class
- Class IVD Annex II List B
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000025020
Other devices from Gold Standard Diagnostics Frankfurt GmbH
See all devices from Gold Standard Diagnostics Frankfurt GmbH →
Properties
Other properties (7)
- Sterile: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No