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ELISA ENA Screen Test Sytem

FDA UDI

by Zeus Scientific, Inc.

Identity

Trade Name
ELISA ENA Screen Test Sytem FDA UDI
Generic Name
Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The ZEUS ELISA ENA Screen Test System is a qualitative screening assay designed to detect antibodies to extractable nuclear antigens (anti-ENA) in human sera. When performed according to the enclosed instructions, this test is capable of detecting all anti-ENAs commonly tested for, such as those against Jo-1, Sm, Sm/RNP, SSA, SSB, and Scl-70. This device is for In Vitro diagnostic use. FDA UDI
Model / Reference
2Z2851G FDA UDI
Description
The ZEUS ELISA ENA Screen Test System is a qualitative screening assay designed to detect antibodies to extractable nuclear antigens (anti-ENA) in human sera. When performed according to the enclosed instructions, this test is capable of detecting all anti-ENAs commonly tested for, such as those against Jo-1, Sm, Sm/RNP, SSA, SSB, and Scl-70. This device is for In Vitro diagnostic use. FDA UDI

Identifiers

Catalog Number
2Z2851G FDA UDI
Primary DI / UDI-DI
00845533000567 FDA UDI
GMDN Term
Multiple extractable nuclear antigen antibody (anti-ENA) 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 extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA)

ELISA ENA Screen Test Sytem by Zeus Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple extractable nuclear antigen antibody (anti-ENA) 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 271146cc-3ad2-4a27-8b01-21112e35ca43 35 fields · synced May 30, 2026