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AtheNA Multi-Lyte® AIV Plus Test System

FDA UDI

by Zeus Scientific, Inc.

Identity

Trade Name
AtheNA Multi-Lyte® AIV Plus Test System FDA UDI
Generic Name
Multiple vasculitis-associated antibody IVD, kit, multiplex FDA UDI
Device Name
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. FDA UDI
Model / Reference
A96101 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
A96101 FDA UDI
Primary DI / UDI-DI
00845533000024 FDA UDI
GMDN Term
Multiple vasculitis-associated antibody IVD, kit, multiplex FDA UDI

Classification

Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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Implantable

No

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Contains Latex

No

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Prescription Use

Yes

FDA UDI

Over-the-Counter

No

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Convenience Kit

Yes

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Combination Product

No

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HCT/P

No

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Premarket Exempt

No

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Lot / Batch Number

Yes

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Serial Number

No

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Expiration Date

Yes

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Manufacturing Date

No

FDA UDI

Category: Multiple vasculitis-associated antibody IVD, kit, multiplex

AtheNA Multi-Lyte® AIV Plus Test System by Zeus Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple vasculitis-associated antibody IVD, kit, multiplex.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zeus Scientific, Inc.

Sources (1)

  • FDA UDI 13e315e2-60e8-4e15-91fd-f9f40d78c339 35 fields · synced May 30, 2026