Identity
- Trade Name
- BioPlex 2200 FDA UDI
- Generic Name
- Treponema pallidum reagin antibody IVD, reagent FDA UDI
- Device Name
- U.S. IFU (United States) Manual & CDs, BioPlex 2200 Syphilis Total & RPR IFU 4.3v2 FDA UDI
- Model / Reference
- 12007240 FDA UDI
- Description
- U.S. IFU (United States) Manual & CDs, BioPlex 2200 Syphilis Total & RPR IFU 4.3v2 FDA UDI
Identifiers
- Catalog Number
- 12007240 FDA UDI
- Primary DI / UDI-DI
- 03610522015597 FDA UDI
- FDA Product Code
- LIP FDA UDIGMQ FDA UDI
- GMDN Term
- Treponema pallidum reagin antibody IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3830 FDA UDI866.3820 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 ca827c6d-703a-4c80-9058-0bd274b294ca 37 fields · synced May 30, 2026