Identity
- Trade Name
- BioPlex 2200 FDA UDI
- Generic Name
- Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- Manual & CDs, EBV IgG IFU, SW4.1v1 FDA UDI
- Model / Reference
- SW4.1_V1 FDA UDI
- Description
- Manual & CDs, EBV IgG IFU, SW4.1v1 FDA UDI
Identifiers
- Catalog Number
- 6651260F FDA UDI
- Primary DI / UDI-DI
- 00847865012614 FDA UDI
- FDA Product Code
- LSE FDA UDI
- GMDN Term
- Epstein-Barr virus (EBV) 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
Similar devices
Also classified as Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay.
- IFA EBV-NA IgG Test System — ZEUS SCIENTIFIC, INC.
- AtheNA Multi-Lyte® EBV IgG Plus Test System — ZEUS SCIENTIFIC, INC.
- BioPlex 2200 — Bio-Rad Laboratories · Class I
- BioPlex 2200 — Bio-Rad Laboratories · Class I
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bio-Rad Laboratories
Sources (1)
- FDA UDI 279b5f54-fa97-4ff8-9253-90444f1700c9 36 fields · synced May 30, 2026