ANTI-LAMBDA 1 mL (DM)
by sebia
Ref 4367
ANTI-LAMBDA 1 mL (DM) (4367) is a device classified as IVD General made by Sebia, registered in EUDAMED on 20 Oct 2026 (Basic UDI-DI B-03607360043677), active as of 7 Nov 2026.
Active
CE IVDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-03607360043677 03607360043677 | Date20 Oct 2026 | StatusActive |
Official records
- EUDAMED public site B-03607360043677
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- Withdrawn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
- 4367
- Primary DI / UDI-DI
- 03607360043677
- Basic UDI-DI
- B-03607360043677
- EMDN code
- W01029001 Antisera (monovalent and polyvalent)
- Device class
- Class IVD General
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- FR-MF-000003520
Similar devices in this category
Other devices filed under OTHER IMMUNOCHEMISTRY.
- Group K Factor 18 PL.6031 by Pro-Lab Diagnostics UK
- Deben Escherichia coli Antisera 295613 by Deben Diagnostics Ltd
- Group C Factor 6, 7 PL.6013 by Pro-Lab Diagnostics UK
- Scorpius KitO100HRP by WellMed BV
- Orion R50AP by WellMed BV
- Dimension Vista®/Dimension® EXL™ CTNI SDIL 10445205 KD692 by Siemens Healthcare Diagnostics Inc.
- Sample Diluent C89915 by SHENZHEN YHLO BIOTECH CO., LTD.
- Dimension® Purified Water Diluent 10444887 710615901 by Siemens Healthcare Diagnostics Inc.
- CL AIA-PACK SAMPLE DILUTING REAGENT C 0029403 by Tosoh Corporation
- ImmunoCAP Dummy ImmunoCAP 14-4317-01 by Phadia AB