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IFA nDNA Test System

FDA UDI

by Zeus Scientific, Inc.

Identity

Trade Name
IFA nDNA Test System FDA UDI
Generic Name
Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay FDA UDI
Device Name
The ZEUS IFA nDNA Test System is a pre-standardized assay designed for the qualitative and semi-quantitative detection of antibodies to native DNA by the Indirect Fluorescent Antibody (IFA) technique and is for In Vitro diagnostic use. FDA UDI
Model / Reference
FA1001 FDA UDI
Description
The ZEUS IFA nDNA Test System is a pre-standardized assay designed for the qualitative and semi-quantitative detection of antibodies to native DNA by the Indirect Fluorescent Antibody (IFA) technique and is for In Vitro diagnostic use. FDA UDI

Identifiers

Primary DI / UDI-DI
00845533001342 FDA UDI
GMDN Term
Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay 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: Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay

IFA nDNA Test System by Zeus Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay.

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 3fef0c95-886b-40be-bf1e-ca58c6721215 34 fields · synced May 30, 2026