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ELISA ANA Screen Smart Kit Test System

FDA UDI

by Zeus Scientific, Inc.

Identity

Trade Name
ELISA ANA Screen Smart Kit Test System FDA UDI
Generic Name
Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The ZEUS ELISA ANA Screen Test System is a qualitative screening assay designed to detect anti-nuclear antibodies (ANA) in human sera. When performed according to these instructions, this test system is capable of detecting all ANAs commonly tested for, such as those against double stranded DNA (dsDNA), Jo-1, Sm, Sm/RNP, SSA, SSB, and Scl-70. The test is also capable of detecting ANA demonstrating centromere, nucleolar, peripheral, and spindle indirect immunofluorescence antibody (IFA) patterns. This test is for In Vitro diagnostic use. FDA UDI
Model / Reference
SM2Z29001G FDA UDI
Description
The ZEUS ELISA ANA Screen Test System is a qualitative screening assay designed to detect anti-nuclear antibodies (ANA) in human sera. When performed according to these instructions, this test system is capable of detecting all ANAs commonly tested for, such as those against double stranded DNA (dsDNA), Jo-1, Sm, Sm/RNP, SSA, SSB, and Scl-70. The test is also capable of detecting ANA demonstrating centromere, nucleolar, peripheral, and spindle indirect immunofluorescence antibody (IFA) patterns. This test is for In Vitro diagnostic use. FDA UDI

Identifiers

Catalog Number
SM2Z29001G FDA UDI
Primary DI / UDI-DI
00845533000147 FDA UDI
GMDN Term
Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA) 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, enzyme immunoassay (EIA)

ELISA ANA Screen Smart Kit 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, enzyme immunoassay (EIA).

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 dbb3b457-4cb9-4271-af74-112af44d5db9 35 fields · synced May 30, 2026