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VALIDATE® Anti-SARS-CoV2 IgG Test Set
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 510mm
Identity
- Trade Name
- VALIDATE® Anti-SARS-CoV2 IgG Test Set EUDAMEDValidate FDA UDI
- Generic Name
- SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control FDA UDI
- Device Name
- VALIDATE® Anti-SARS-CoV2 IgG Test Set EUDAMEDValidate SARS-Cov2 IgG Single clinical chemistry analyte IVD, control FDA UDI
- Model / Reference
- 510mm EUDAMEDFDA UDI
- Description
- Validate SARS-Cov2 IgG Single clinical chemistry analyte IVD, control FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850011135402 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00850011135402 EUDAMED
- FDA Product Code
- JJX FDA UDI
- EMDN Code
- W0105080804 OTHER VIROLOGY CONTROLS - INF.IMM. EUDAMED
- GMDN Term
- SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control FDA UDI
Classification
- Device Class
- Class IVD General 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
Yes
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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® Anti-SARS-CoV2 IgG Test Set by LGC Clinical Diagnostics, Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00850011135402 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- LGC Clinical Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000029697
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (2)
- EUDAMED 568daa0c-a089-452f-bf44-3162da18740c 61 fields · synced Jul 29, 2026
- FDA UDI 4d281ff4-01c7-4262-8a13-6a254eb08a00 34 fields · synced May 30, 2026