Gamma-Quin

FDA UDI

Class II (US FDA UDI)

by Immucor, Inc.

Identity

Trade Name: Gamma-Quin FDA UDI
Generic Name: Immunoglobulin removal reagent IVD FDA UDI
Device Name: Gamma-Quin is intended for use in removing red cell-bound immunoglobulin. Gamma-Quin is an approximately 16% solution of chloroquine diphosphate in phosphate-buffered saline at a pH of about 5.0. This package configuration is one (1) vial of 10 mL volume. FDA UDI
Model / Reference: 0007890 FDA UDI
Description: Gamma-Quin is intended for use in removing red cell-bound immunoglobulin. Gamma-Quin is an approximately 16% solution of chloroquine diphosphate in phosphate-buffered saline at a pH of about 5.0. This package configuration is one (1) vial of 10 mL volume. FDA UDI

Identifiers

Catalog Number: 0007890 FDA UDI
Primary DI / UDI-DI: 10888234000891 FDA UDI
510(k) Number: K813342 FDA UDI
FDA Product Code: KSK FDA UDI
GMDN Term: Immunoglobulin removal reagent IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.9400 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Immunoglobulin removal reagent IVD

Gamma-Quin by Immucor, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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ZORBA IgG Removal Reagent — ZEUS SCIENTIFIC, 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 II	Pending data

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Manufacturer

Manufacturer: Immucor, Inc.

Sources (1)

FDA UDI 7034dd6a-b19d-4bf3-b045-fdad144cc37c 37 fields · synced Jun 8, 2026