Quantitative determination of IgG subclass 3 in human serum and plasma on BN II and BN ProSpec® Systems

Quantitative determination of IgG subclass 3 in human serum and plasma on BN II and BN ProSpec® Systems
N Latex IgG3 - 10445972

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 one or multiple immunoglobulin G subclasses (IgG subclasses) in a clinical specimen.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DAS

Device Name: Igg (Fc Fragment Specific), Antigen, Antiserum, Control

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

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: 866.5530

Third Party Flag: N

Medical Specialty: IM

Device Id: 00842768006708

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