Identity
- Trade Name
- VALIDATE® HEPARIN Test Set EUDAMEDValidate FDA UDI
- Generic Name
- Heparin anti-Xa IVD, control FDA UDI
- Device Name
- VALIDATE® HEPARIN Test Set EUDAMEDValidate Heparin is intended for the quantitative determination of Calibration Verification/Linearity of the heparin anti-Xa activityon automated instruments FDA UDI
- Model / Reference
- 903st EUDAMEDFDA UDI
- Description
- Validate Heparin is intended for the quantitative determination of Calibration Verification/Linearity of the heparin anti-Xa activityon automated instruments FDA UDI
Identifiers
- Catalog Number
- 903st FDA UDI
- Primary DI / UDI-DI
- 00859110005104 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00859110005104 EUDAMED
- FDA Product Code
- GGN FDA UDI
- EMDN Code
- W0103020799 HAEMOSTASIS CONTROLS - OTHER EUDAMED
- GMDN Term
- Heparin anti-Xa 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
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® HEPARIN 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-00859110005104 | 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 b0b76349-30e4-4bd9-8937-b47011c112ae 61 fields · synced Jun 20, 2026
- FDA UDI af3ca1ce-16cc-4b66-80d7-3b8c8ba6527d 37 fields · synced May 30, 2026