Identity
- Trade Name
- BioPlex 2200 FDA UDI
- Generic Name
- Measles virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- MMRV IgG Reagent Pack FDA UDI
- Model / Reference
- 6652450 FDA UDI
- Description
- MMRV IgG Reagent Pack FDA UDI
Identifiers
- Catalog Number
- 6652450 FDA UDI
- Primary DI / UDI-DI
- 00847865000765 FDA UDI
- FDA Product Code
- LFY FDA UDILJY FDA UDIOPL FDA UDILJB FDA UDI
- GMDN Term
- Measles virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay 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
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Measles virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassayRubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassayMumps virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassayVaricella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
BioPlex 2200 by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay.
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- BioPlex 2200 — Bio-Rad Laboratories · Class I
- BioPlex 2200 — Bio-Rad Laboratories · Class II
- 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 61f80232-3f93-426a-b36f-404a5ba5c8ec 37 fields · synced May 30, 2026