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BioPlex® 2200

FDA UDI

Class II (US FDA UDI)

by Bio-Rad Laboratories

Identity

Trade Name
BioPlex® 2200 FDA UDI
Generic Name
Laboratory instrument/analyser application software IVD FDA UDI
Device Name
BioPlex® 2200 HIV Ag-Ab Assay Protocol Files CD SW4.2_v4 FDA UDI
Model / Reference
SW4.2_v4 FDA UDI
Description
BioPlex® 2200 HIV Ag-Ab Assay Protocol Files CD SW4.2_v4 FDA UDI

Identifiers

Catalog Number
6653475A FDA UDI
Primary DI / UDI-DI
03610520519813 FDA UDI
FDA Product Code
MZF FDA UDI
GMDN Term
Laboratory instrument/analyser application software IVD 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: Laboratory instrument/analyser application software IVD

BioPlex® 2200 by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laboratory instrument/analyser application software IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bio-Rad Laboratories

Sources (1)

  • FDA UDI 76eff57e-f6e4-4365-9257-ee3011756db7 36 fields · synced May 29, 2026