Atlas CRP Latex Kit, 100 Tests (4ml Latex, 2x0.5ml Controls, Glass slide Stirring sticks).
Ref 8.00.00.1.0100
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-04260658557141 04260658557141 | Date22 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- Withdrawn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
- 8.00.00.1.0100
- Primary DI / UDI-DI
- 04260658557141
- Basic UDI-DI
- B-04260658557141
- EMDN Code
- W01021109 C-reactive protein
- 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 (7)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No