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dsDNA (Crithidia l.)

FDA UDI

by Zeus Scientific, Inc.

Identity

Trade Name
dsDNA (Crithidia l.) FDA UDI
Generic Name
Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay FDA UDI
Device Name
The dsDNA (Crithidia l.) kit 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 dsDNA (Crithidia l.) kit 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

Catalog Number
FA1001 FDA UDI
Primary DI / UDI-DI
00845533001908 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

dsDNA (Crithidia l.) 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 41d99911-fd89-4fe4-bd85-979999431bc5 35 fields · synced May 30, 2026