Positive Control Flu
by TAUNS Laboratories, Inc. EUDAMED
Active
Ref ACPC7111
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-04987815071110 | Date7 Mar 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Model / Reference
- ACPC7111
- Primary DI / UDI-DI
- 04987815071110
- Basic UDI-DI
- B-04987815071110
- EMDN Code
- W0105094001 Controls infectious immunology - rt & poc
- Device Class
- Class IVD General
- Market of Registration
- Latvia
Manufacturer details
- EUDAMED SRN
- JP-MF-000007041
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from TAUNS Laboratories, Inc.
Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No