Identity
- Trade Name
- BioPlex 2200 FDA UDI
- Generic Name
- Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, calibrator FDA UDI
- Device Name
- MMRV IgG Calibrator Lot Data FDA UDI
- Model / Reference
- 6632420 FDA UDI
- Description
- MMRV IgG Calibrator Lot Data FDA UDI
Identifiers
- Catalog Number
- 6632420 FDA UDI
- Primary DI / UDI-DI
- 00847865000734 FDA UDI
- FDA Product Code
- LFY FDA UDILJY FDA UDIOPL FDA UDILJB FDA UDI
- GMDN Term
- Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3900 FDA UDI866.3380 FDA UDI866.3510 FDA UDI866.3520 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: Rubella virus immunoglobulin G (IgG) antibody IVD, calibratorMumps virus immunoglobulin G (IgG) antibody IVD, calibratorVaricella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, calibratorMeasles virus 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 Mumps virus 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 a01ec960-1ada-40f6-a3a0-d5c14412d681 36 fields · synced Jun 1, 2026