The DRG ELISA Proteinase-3 (PR-3) Test System is intended for the qualitative and semi-quantitative detection of IgG-class antibody to proteninase-3 in human serum. The test is intended to be used as an aid in the diagnosis of various autoimmune vasculitic disorders characterized by elevated levels of anti-neutrophil cytoplasmic antibodies (ANCA). ANCA may be associated with autoimmune disorders such as Wegener's granulomatosis, ICGN, MPA and PRS

The DRG ELISA Proteinase
Proteinase-3 IgG ELISA - EIA-2778

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-neutrophil cytoplasmic antibodies (ANCA) to proteinase 3 (PR3) in a clinical specimen, using a multiplex method.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: MOB

Device Name: Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

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: 00840239027788

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