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.

Gamma
Gamma-Quin - 0007890

A substance or reactant intended to be used alone or in combination with other IVDs for the removal, adsorption, absorption, or inactivation of non-specific immunoglobulins and/or rheumatoid factor antibodies present in a clinical specimen, to prevent interference when testing for other specific classes of immunoglobulin.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: KSK

Device Name: Solution, Stabilized Enzyme

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: HE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 864.9400

Third Party Flag: N

Medical Specialty: HE

Device Id: 10888234000891

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A