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AtheNA Multi-Lyte® ANA-II Plus Test System

FDA UDI

by Zeus Scientific, Inc.

Identity

Trade Name
AtheNA Multi-Lyte® ANA-II Plus Test System FDA UDI
Generic Name
Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex FDA UDI
Device Name
The ZEUS AtheNA Multi-Lyte® ANA-II Plus Test System is intended for the semi-quantitative detection of IgG class antibody to eight separate analytes (SSA, SSB, Sm, RNP, Scl-70, Jo-1, Centromere B, and Histone) in human serum, the quantitative detection of IgG class antibody to dsDNA in human serum, and the qualitative detection of IgG class antibody to ANA. The test system is intended to be used as an aid in the diagnosis of various systemic autoimmune disorders. This test is for In Vitro diagnostic use. FDA UDI
Model / Reference
A21101 FDA UDI
Description
The ZEUS AtheNA Multi-Lyte® ANA-II Plus Test System is intended for the semi-quantitative detection of IgG class antibody to eight separate analytes (SSA, SSB, Sm, RNP, Scl-70, Jo-1, Centromere B, and Histone) in human serum, the quantitative detection of IgG class antibody to dsDNA in human serum, and the qualitative detection of IgG class antibody to ANA. The test system is intended to be used as an aid in the diagnosis of various systemic autoimmune disorders. This test is for In Vitro diagnostic use. FDA UDI

Identifiers

Catalog Number
A21101 FDA UDI
Primary DI / UDI-DI
00845533000017 FDA UDI
GMDN Term
Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex FDA UDI

Classification

Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex

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

Similar devices

Also classified as Multiple antinuclear antibody (ANA) screening 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 54548422-74c9-4de4-86c8-f6eb4553ef20 35 fields · synced May 30, 2026