Identity
- Trade Name
- BioPlex 2200 FDA UDI
- Generic Name
- Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, calibrator FDA UDI
- Device Name
- EBV IgG Calibrator Lot Data FDA UDI
- Model / Reference
- 6631220 FDA UDI
- Description
- EBV IgG Calibrator Lot Data FDA UDI
Identifiers
- Catalog Number
- 6631220 FDA UDI
- Primary DI / UDI-DI
- 00847865000130 FDA UDI
- FDA Product Code
- JIX FDA UDI
- GMDN Term
- Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
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) early antigen (EA) immunoglobulin G (IgG) antibody IVD, calibratorEpstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, calibratorEpstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, calibrator
BioPlex 2200 by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, calibrator.
- BioPlex 2200 — Bio-Rad Laboratories · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Bio-Rad Laboratories
Sources (1)
- FDA UDI ec12526d-2cf6-4025-ba3c-0f804d24c070 36 fields · synced May 30, 2026