Identity
- Trade Name
- BioPlex® 2200 FDA UDI
- Generic Name
- HIV1/HIV2 antigen/antibody IVD, calibrator FDA UDI
- Device Name
- BioPlex 2200, HIV Ag-Ab Calibrator Lot Data FDA UDI
- Model / Reference
- 6633420 FDA UDI
- Description
- BioPlex 2200, HIV Ag-Ab Calibrator Lot Data FDA UDI
Identifiers
- Catalog Number
- 6633420 FDA UDI
- Primary DI / UDI-DI
- 00847865018470 FDA UDI
- FDA Product Code
- MZF FDA UDI
- GMDN Term
- HIV1/HIV2 antigen/antibody IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3956 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: HIV1/HIV2 antigen/antibody IVD, calibrator
BioPlex® 2200 by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as HIV1/HIV2 antigen/antibody IVD, calibrator.
- Alinity — Abbott
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- ACCESS HIV Ag/Ab combo Calibrators — Beckman Coulter, Inc. · Class II
- Alinity — Abbott · Class II
- GS — Bio-Rad Laboratories · Class II
- BioPlex® 2200 — Bio-Rad Laboratories · Class II
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 ae760cfd-b8dd-4f27-b571-012254399eba 36 fields · synced Jun 6, 2026