Identity
- Trade Name
- BioPlex 2200 FDA UDI
- Generic Name
- Measles virus immunoglobulin G (IgG) antibody IVD, control FDA UDI
- Device Name
- MMRV IgG Control Set FDA UDI
- Model / Reference
- 6632430 FDA UDI
- Description
- MMRV IgG Control Set FDA UDI
Identifiers
- Catalog Number
- 6632430 FDA UDI
- Primary DI / UDI-DI
- 00847865000741 FDA UDI
- FDA Product Code
- LJB FDA UDILJY FDA UDIOPL FDA UDILFY FDA UDI
- GMDN Term
- Measles virus immunoglobulin G (IgG) antibody IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3520 FDA UDI866.3380 FDA UDI866.3510 FDA UDI866.3900 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 1.5 Milliliter FDA UDI
Category: Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, controlRubella virus immunoglobulin G (IgG) antibody IVD, controlMeasles virus immunoglobulin G (IgG) antibody IVD, controlMumps virus immunoglobulin G (IgG) antibody IVD, control
BioPlex 2200 by Bio-Rad Laboratories — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Measles virus immunoglobulin G (IgG) antibody IVD, control.
- Measles IgG Control — BION ENTERPRISES, LTD. · Class I
- LIAISON® Control Measles IgG — Diasorin Inc.
- Measles Negative Control — BION ENTERPRISES, LTD. · Class I
- VIROTROL MuMZ — Bio-Rad Laboratories · Class I
- VIROCLEAR MuMZ — Bio-Rad Laboratories · Class I
- BioPlex 2200 — Bio-Rad Laboratories · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
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 b0215508-2d4c-47e2-a1cd-190a89a7bbbd 37 fields · synced Jun 8, 2026