Identity
- Trade Name
- BioPlex 2200 FDA UDI
- Generic Name
- Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- U.S. IFU, Manual & CDs, BioPlex 2200 ToRC IgM IFU SW4.3_v1 FDA UDI
- Model / Reference
- 4.3_v1 FDA UDI
- Description
- U.S. IFU, Manual & CDs, BioPlex 2200 ToRC IgM IFU SW4.3_v1 FDA UDI
Identifiers
- Catalog Number
- 12005791 FDA UDI
- Primary DI / UDI-DI
- 03610521167488 FDA UDI
- FDA Product Code
- PUQ FDA UDILFZ FDA UDILGD FDA UDILKQ FDA UDI
- GMDN Term
- Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3510 FDA UDI866.3175 FDA UDI866.3780 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: Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassayCytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassayRubella virus immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
BioPlex 2200 by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rubella virus immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay.
- 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 308f257b-2730-459a-9ddc-70d14ad85a6a 36 fields · synced May 30, 2026