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ELISA ENA Screen Smart Kit Test Sytem

FDA UDI

by Zeus Scientific, Inc.

Identity

Trade Name
ELISA ENA Screen Smart Kit 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
SM2Z2851G 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
SM2Z2851G FDA UDI
Primary DI / UDI-DI
00845533000574 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 Smart Kit 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 c8a8c4c2-129b-486a-a3a0-0c1a394cf3c5 35 fields · synced May 29, 2026