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Total Antioxidant Status (tas Control)
EUDAMEDFDA UDIClass B (EU MDR)
Ref NX2331
Identity
- Trade Name
- TOTAL ANTIOXIDANT STATUS (TAS CONTROL) EUDAMED"TOTAL ANTIOXIDANT STATUS (TAS CONTROL)" FDA UDI
- Generic Name
- Antioxidant capacity IVD, control FDA UDI
- Device Name
- TOTAL ANTIOXIDANT STATUS CONTROL EUDAMEDThis product is intended for use in the control of the Randox Total Antioxidant Status assay, FDA UDI
- Model / Reference
- NX2331 EUDAMEDFDA UDI
- Description
- This product is intended for use in the control of the Randox Total Antioxidant Status assay, FDA UDI
Identifiers
- Catalog Number
- NX2331 FDA UDI
- Primary DI / UDI-DI
- 05055273204728 EUDAMEDFDA UDI
- Basic UDI-DI
- 50552732BTTATSS111Y8 EUDAMED
- FDA Product Code
- JJX FDA UDI
- EMDN Code
- W0101050299 SPECIFIC CONTROLS (CC) - OTHER EUDAMED
- GMDN Term
- Antioxidant capacity IVD, control FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Market of Registration
- Northern 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
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
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
Total Antioxidant Status (tas Control) by Randox Laboratories Limited — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 50552732BTTATSS111Y8 | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Randox Laboratories Limited
- EUDAMED SRN
- XI-MF-000028410
Sources (2)
- EUDAMED bb5c6d56-ec13-42a7-b4a4-147ab23d0ed4 61 fields · synced Jul 15, 2026
- FDA UDI e197f31a-45f5-48ed-801c-075f919ec10b 36 fields · synced May 30, 2026