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VALIDATE® BODY FLUIDS 3 Test Set
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 207RO
Identity
- Trade Name
- VALIDATE® BODY FLUIDS 3 Test Set EUDAMEDValidate FDA UDI
- Generic Name
- Cancer antigen 19-9 (CA19-9) IVD, control FDA UDI
- Device Name
- VALIDATE® BODY FLUIDS 3 Test Set EUDAMEDValidate Body Fluids 3 is intended for quantitative determination of Calibration Verification/Linearity on Automated Instruments. FDA UDI
- Model / Reference
- 207RO EUDAMEDFDA UDI
- Description
- Validate Body Fluids 3 is intended for quantitative determination of Calibration Verification/Linearity on Automated Instruments. FDA UDI
Identifiers
- Catalog Number
- 207ro FDA UDI
- Primary DI / UDI-DI
- 00850011135389 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00850011135389 EUDAMED
- FDA Product Code
- JJY FDA UDI
- EMDN Code
- W0101050101,W0101050102 EUDAMED
- GMDN Term
- Cancer antigen 19-9 (CA19-9) 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® BODY FLUIDS 3 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-00850011135389 | 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 6e4be51f-b321-4785-8559-656b41d04afb 61 fields · synced Jun 18, 2026
- FDA UDI 130be38f-0995-4f9f-9981-c3f34900a803 36 fields · synced May 30, 2026