The IgG test system is a device intended for the quantitative in vitro determination of immunoglobulin G (IgG) concentration in serum and plasma

The IgG test system is a device intended for the quantitative in vitro determination of immunoglobulin G (IgG) concentration in serum and plasma
IgG - IG2448

One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of total immunoglobulin G (IgG total) in a clinical specimen.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DEW

Device Name: Igg, Antigen, Antiserum, Control

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: IM

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: 866.5510

Third Party Flag: Y

Medical Specialty: IM

Device Id: 05055273203936

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