Identity
- Trade Name
- VALIDATE® D-DIMER Test Set EUDAMEDValidate FDA UDI
- Generic Name
- D-dimer IVD, control FDA UDI
- Device Name
- VALIDATE® D-DIMER Test Set EUDAMEDValidate D-Dimer is intended for the quantitative determination of Calibration Verification/Linearity of drug analytes on automated instruments. FDA UDI
- Model / Reference
- 902se EUDAMEDFDA UDI
- Description
- Validate D-Dimer is intended for the quantitative determination of Calibration Verification/Linearity of drug analytes on automated instruments. FDA UDI
Identifiers
- Catalog Number
- 902se FDA UDI
- Primary DI / UDI-DI
- 00859110005081 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00859110005081 EUDAMED
- FDA Product Code
- GGN FDA UDI
- EMDN Code
- W0102152002 HORMONE CONTROLS EUDAMED
- GMDN Term
- D-dimer IVD, control FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 864.5425 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
VALIDATE® D-DIMER Test Set by LGC Clinical Diagnostics, Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-00859110005081 | 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 9c03a2c6-fc70-49f2-9ce0-2057bb00e5bf 61 fields · synced Jul 9, 2026
- FDA UDI c8fa4edd-c2be-4c1c-bf01-7ff137a133ed 37 fields · synced May 29, 2026