Identity
- Trade Name
- BioPlex 2200 FDA UDI
- Generic Name
- Rubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- U.S. IFU, Manual & CDs, ToRC IgG IFU, SW4.1_v1 FDA UDI
- Model / Reference
- SW4.1_1 FDA UDI
- Description
- U.S. IFU, Manual & CDs, ToRC IgG IFU, SW4.1_v1 FDA UDI
Identifiers
- Catalog Number
- 6651665E FDA UDI
- Primary DI / UDI-DI
- 00847865011075 FDA UDI
- FDA Product Code
- OMI FDA UDI
- GMDN Term
- Rubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3510 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: Rubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassayToxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassayCytomegalovirus (CMV) 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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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 cc589741-55ac-48b8-907b-d8497c15a394 36 fields · synced May 30, 2026