BioPlex 2200

FDA UDI

Class II (US FDA UDI)

by Bio-Rad Laboratories

Identity

Trade Name: BioPlex 2200 FDA UDI
Generic Name: Buffered wash solution IVD FDA UDI
Device Name: BioPlex 2200 Instrument Sheath Fluid, 2 X 4L FDA UDI
Model / Reference: 660-0817 FDA UDI
Description: BioPlex 2200 Instrument Sheath Fluid, 2 X 4L FDA UDI

Identifiers

Catalog Number: 6600817 FDA UDI
Primary DI / UDI-DI: 03610520010150 FDA UDI
FDA Product Code: NSU FDA UDI
GMDN Term: Buffered wash solution IVD 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Buffered wash solution IVD

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

Similar devices

Also classified as Buffered wash solution IVD.

ADVIA Centaur® Wash 1 — Siemens Healthcare Diagnostics · Class I
ADVIA Centaur® PW3 — Siemens Healthcare Diagnostics · Class I
CELL-DYN — Abbott Laboratories, Inc. · Class I
VENTANA HE 600 Wash — Ventana Medical Systems · Class I
TBS Auto Wash Buffer 20X — BIOCARE MEDICAL, LLC · Class I
ADVIA Centaur® PW 4 — Siemens Healthcare Diagnostics · Class I
COBAS® AMPLICOR Wash Buffer — Roche Molecular Systems, Inc.
ISE Buffer Reagent — DIAMOND DIAGNOSTICS Inc

Cleared under the same submission

BK140112 also covers:

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 58db2a33-73f5-4d4f-bcb9-0623ce68a0af 38 fields · synced Jun 8, 2026