AtheNA Multi-Lyte® AIV Plus Test System A96101

GUDID 00845533000024

The ZEUS AtheNA Multi-Lyte® Autoimmune Vasculitis (AIV) Plus Test System is intended for the qualitative and semi-quantitative detection of IgG class antibody to three separate antigens; Glomerular Basement Membrane (GBM), Myeloperoxidase (MPO) and Proteinase 3(PR-3) in human serum. The test system is intended to be used as an aid in the diagnosis of various autoimmune vasculitic disorders characterized by elevated levels of selected autoantibodies. MPO and/or PR-3 may be associated with autoimmune disorders such as Wegener’s Granulomatosis, ICGN, MPA and PRS. Anti-GBM antibodies aid in the diagnosis of Goodpasture’s syndrome. This test is for In Vitro diagnostic use only.

ZEUS SCIENTIFIC, INC.

Multiple vasculitis-associated antibody IVD, kit, multiplex

• Primary Device ID: 00845533000024
• NIH Device Record Key: 13e315e2-60e8-4e15-91fd-f9f40d78c339
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AtheNA Multi-Lyte® AIV Plus Test System
• Version Model Number: A96101
• Catalog Number: A96101
• Company DUNS: 080953946
• Company Name: ZEUS SCIENTIFIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845533000024 [Primary]

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

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