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VALIDATE® HS Troponin Test Set
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 405ab
Identity
- Trade Name
- VALIDATE® HS Troponin Test Set EUDAMEDValidate FDA UDI
- Generic Name
- Troponin T/Troponin I IVD, control FDA UDI
- Device Name
- VALIDATE® HS Troponin Test Set EUDAMEDValidate High Sensitive Troponin I is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. FDA UDI
- Model / Reference
- 405ab EUDAMEDFDA UDI
- Description
- Validate High Sensitive Troponin I is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. FDA UDI
Identifiers
- Catalog Number
- 405ab FDA UDI
- Primary DI / UDI-DI
- 00850011135280 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00850011135280 EUDAMED
- FDA Product Code
- JJX FDA UDI
- EMDN Code
- W0102152004 CARDIAC MARKER CONTROLS EUDAMED
- GMDN Term
- Troponin T/Troponin I 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
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® HS Troponin 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-00850011135280 | 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 87f7987d-f289-454c-8978-e3c314246a0e 61 fields · synced Jul 12, 2026
- FDA UDI 0e15afe1-369d-4082-ae22-cd8498a3951a 37 fields · synced May 30, 2026