Identity
- Trade Name
- BioPlex 2200 FDA UDI
- Generic Name
- Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- EBV IgG Assay Protocol File CD, SW4.1_v1, US FDA UDI
- Model / Reference
- SW4.1_V1 FDA UDI
- Description
- EBV IgG Assay Protocol File CD, SW4.1_v1, US FDA UDI
Identifiers
- Catalog Number
- 6651270D FDA UDI
- Primary DI / UDI-DI
- 00847865012607 FDA UDI
- FDA Product Code
- LSE FDA UDI
- GMDN Term
- Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3235 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassayEpstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassayEpstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
BioPlex 2200 by Bio-Rad Laboratories — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- BioPlex 2200 — Bio-Rad Laboratories · Class I
- BioPlex 2200 — Bio-Rad Laboratories · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bio-Rad Laboratories
Sources (1)
- FDA UDI ef9872af-d346-4fa1-b470-85b33bc11459 36 fields · synced Jun 6, 2026