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SEROLOGY ToRCH EBV POSITIVE CONTROL (ToRCH EBV CONTROL +)
EUDAMEDFDA UDIClass B (EU MDR)
Ref SR10350
Identity
- Trade Name
- SEROLOGY ToRCH EBV POSITIVE CONTROL (ToRCH EBV CONTROL +) EUDAMEDFDA UDI
- Generic Name
- Multiple infectious organism/newborn TORCH screen IVD, control FDA UDI
- Device Name
- SEROLOGY ToRCH CONTROL EUDAMEDToRCH EBV Positive Control is intended for use with in vitro assays for determination of IgG and IgM antibodies to the viral capsid antigen of Epstein-Barr Virus (EBV VCA) and IgG antibodies to the viral polypeptide nuclear antigen of Epstein-Barr Virus (EBV EBNA). ToRCH EBV Positive Control is unassayed without target values and is suitable for use on many analysers. This control must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay. ToRCH EBV Positive Control is helpful in determining the precision of testing systems and in identifying sources of variation. FDA UDI
- Model / Reference
- SR10350 EUDAMEDFDA UDI
- Description
- ToRCH EBV Positive Control is intended for use with in vitro assays for determination of IgG and IgM antibodies to the viral capsid antigen of Epstein-Barr Virus (EBV VCA) and IgG antibodies to the viral polypeptide nuclear antigen of Epstein-Barr Virus (EBV EBNA). ToRCH EBV Positive Control is unassayed without target values and is suitable for use on many analysers. This control must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay. ToRCH EBV Positive Control is helpful in determining the precision of testing systems and in identifying sources of variation. FDA UDI
Identifiers
- Catalog Number
- SR10350 FDA UDI
- Primary DI / UDI-DI
- 05055273216431 EUDAMEDFDA UDI
- Basic UDI-DI
- 50552732BSETECO123LF EUDAMED
- FDA Product Code
- OHQ FDA UDI
- EMDN Code
- W0105080807 MULTICONSTITUENT CONTROLS - INF.IMM. EUDAMED
- GMDN Term
- Multiple infectious organism/newborn TORCH screen 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
SEROLOGY ToRCH EBV POSITIVE CONTROL (ToRCH EBV CONTROL +) by Randox Laboratories Limited — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 50552732BSETECO123LF | 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 10888118-9e01-493b-a5c2-8172c93474fc 61 fields · synced Jun 20, 2026
- FDA UDI 009ca915-5f13-4a74-a7ab-bb56a81b41fc 36 fields · synced May 27, 2026