AGPA Positive Control

AGPA Positive Control
IMMCO DIAGNOSTICS - 2212

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 screening for one or multiple antibodies associated with liver disease in a clinical specimen. The assayed antibodies may include autoimmune antibodies directed at liver-kidney microsome 1 protein (anti-LKM1), smooth muscle (anti-SMA), F-Actin, soluble liver antigen (SLA), Sp-100 protein, glycoprotein-210 (gp210), lamin B receptor (LBR) and also liver cytosol specific antibody type 1 (anti-LC1) and/or antimitochondrial antibodies (AMA).

• ml

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DBL

Device Name: Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, 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: 866.5660

Third Party Flag: Y

Medical Specialty: IM

Device Id: 00845714001918

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