Identity
- Trade Name
- BioPlex 2200 FDA UDI
- Generic Name
- Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- Manual & CDs, Rubella & CMV IgM IFU, SW4.1_v1, U.S Only FDA UDI
- Model / Reference
- SW4.1_V1 FDA UDI
- Description
- Manual & CDs, Rubella & CMV IgM IFU, SW4.1_v1, U.S Only FDA UDI
Identifiers
- Catalog Number
- 6653860D FDA UDI
- Primary DI / UDI-DI
- 00847865012577 FDA UDI
- FDA Product Code
- LFX FDA UDILKQ FDA UDILFZ 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 UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
BioPlex 2200 by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Bio-Rad Laboratories
Sources (1)
- FDA UDI 0e808ac0-87de-40fd-bce9-1f750bb6c5f1 37 fields · synced May 30, 2026