Identity
- Trade Name
- BioPlex 2200 FDA UDI
- Generic Name
- Multiplex analyser IVD, laboratory, automated FDA UDI
- Device Name
- BioPlex 2200 Instrument FDA UDI
- Model / Reference
- 6600000 FDA UDI
- Description
- BioPlex 2200 Instrument FDA UDI
Identifiers
- Catalog Number
- 6600000 FDA UDI
- Primary DI / UDI-DI
- 00847865002813 FDA UDI
- FDA Product Code
- NSU FDA UDI
- GMDN Term
- Multiplex analyser IVD, laboratory, automated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.2570 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multiplex analyser IVD, laboratory, automated
BioPlex 2200 by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiplex analyser IVD, laboratory, automated.
- Randox Evidence™ — Randox Laboratories, Ltd. · Class I
- BioPlex 2200 — Bio-Rad Laboratories · Class II
Cleared under the same submission
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 dfe2023f-e5d0-4843-ade8-e4a4354e5fb8 38 fields · synced Jun 1, 2026