An IgE test system is a device intended for the quantitative in vitro determination of immunoglobulin E (IgE) concentration in human serum or plasma

An IgE test system is a device intended for the quantitative in vitro determination of immunoglobulin E (IgE) concentration in human serum or plasma
IgE - IE7308

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of immunoglobulin E (IgE) antibodies to one or multiple allergens and total immunoglobulin E (IgE total) antibodies in a clinical specimen.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DGC

Device Name: Ige, 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: 05055273203929

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