Hemolysis and Wash Solution

FDA UDI

Class I (US FDA UDI)

by Tosoh Bioscience, Inc.

Identity

Trade Name: Hemolysis and Wash Solution FDA UDI
Generic Name: Buffered wash solution IVD FDA UDI
Device Name: Red Cell Lysing Reagent FDA UDI
Model / Reference: 018431US FDA UDI
Description: Red Cell Lysing Reagent FDA UDI

Identifiers

Primary DI / UDI-DI: 00853931008030 FDA UDI
FDA Product Code: GGK FDA UDI
GMDN Term: Buffered wash solution IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.8540 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Buffered wash solution IVD

Hemolysis and Wash Solution by Tosoh Bioscience, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Buffered wash solution IVD.

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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

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 I	Pending data

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Manufacturer

Manufacturer: Tosoh Bioscience, Inc.

Sources (1)

FDA UDI 7ca72db7-ca96-42bc-9d73-f446bc3bb06a 34 fields · synced May 30, 2026