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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
Phospholipid antibody IVD, kit, multiplex FDA UDI
Device Name
Manual & CDs, APLS IgA IFU, SW4.1_v1, US Only FDA UDI
Model / Reference
SW4.1_1 FDA UDI
Description
Manual & CDs, APLS IgA IFU, SW4.1_v1, US Only FDA UDI

Identifiers

Catalog Number
6652165B FDA UDI
Primary DI / UDI-DI
00847865012997 FDA UDI
FDA Product Code
MID FDA UDI
MSV FDA UDI
GMDN Term
Phospholipid antibody IVD, kit, multiplex FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5660 FDA UDI
Commercial Distribution
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

Category: Phospholipid antibody IVD, kit, multiplex

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

Similar devices

Also classified as Phospholipid antibody IVD, kit, multiplex.

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 39affccc-3c0c-42eb-b259-5f58af19f5aa 36 fields · synced Jun 6, 2026