Identity
- Trade Name
- VALIDATE EUDAMEDFDA UDI
- Generic Name
- Hepatitis B virus surface immunoglobulin G (IgG) antibody IVD, control FDA UDI
- Device Name
- VALIDATE® aHBs Test Set EUDAMEDaHBs Calibration Verification / Linearity Test kit FDA UDI
- Model / Reference
- 801mm EUDAMEDFDA UDI
- Description
- aHBs Calibration Verification / Linearity Test kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850011135495 EUDAMEDFDA UDI
- Basic UDI-DI
- 008500111358017M EUDAMED
- FDA Product Code
- JJX FDA UDI
- EMDN Code
- W0102152099 CONTROLS- IMMUNOCHEMISTRY - OTHER EUDAMED
- GMDN Term
- Hepatitis B virus surface immunoglobulin G (IgG) antibody IVD, control FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Validate by LGC Clinical Diagnostics, Inc. — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 008500111358017M | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- LGC Clinical Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000029697
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (2)
- EUDAMED 1d3b0508-ca05-4c05-9857-c9537406bb04 61 fields · synced Jun 9, 2026
- FDA UDI fff8803f-0e36-47f5-a50e-1df503a19f5e 34 fields · synced May 30, 2026