Identity
- Trade Name
- BioPlex 2200 FDA UDI
- Generic Name
- Buffered sample diluent IVD, manual FDA UDI
- Device Name
- BioPlex 2200 Sample Dilution Buffer (1X), 120 mL FDA UDI
- Model / Reference
- 12006863 FDA UDI
- Description
- BioPlex 2200 Sample Dilution Buffer (1X), 120 mL FDA UDI
Identifiers
- Catalog Number
- 12006863 FDA UDI
- Primary DI / UDI-DI
- 03610522004980 FDA UDI
- FDA Product Code
- GMQ FDA UDILIP FDA UDI
- GMDN Term
- Buffered sample diluent IVD, manual FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3820 FDA UDI866.3830 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 120 Milliliter FDA UDI
Category: Buffered sample diluent IVD, manual
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
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 3fa36d5d-7833-4e68-b556-02d384a3aafe 37 fields · synced Jun 8, 2026