Atlas Salmonella Antigen Set, Widal Kit (6 Antigens: OA, OB, OD, HA, HB, HD) with 2x1.0ml Controls
Ref 8.01.18.1.0030
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-04260658555970 04260658555970 | Date1 Jul 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- Withdrawn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
- Model / Reference
- 8.01.18.1.0030
- Primary DI / UDI-DI
- 04260658555970
- Basic UDI-DI
- B-04260658555970
- EMDN Code
- W0105011003, W0105011601
- Device Class
- Class IVD General
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000029961
Other devices from Atlas Medical GmbH
Properties
Other properties (6)
- Sterile: No
- Human Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No