Fuller Laboratories by VMRD Bartonella henselae IFA Human IgM Antibody Kit
by VMRD, Inc. EUDAMED
Active
Ref BHM-120
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-00850078245021 | Date6 Nov 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Device Name
- Bartonella henselae IFA Human IgM Antibody Kit
- Model / Reference
- BHM-120
- Primary DI / UDI-DI
- 00850078245021
- Basic UDI-DI
- B-00850078245021
- EMDN Code
- W0105011799 Bacteriology immunoassay - other
- Device Class
- Class IVD General
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- US-MF-000049394
- Authorised representative
- MediMark Europe Sarl. FR-AR-000000182
Other devices from VMRD, Inc.
Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No