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IgG Anti-nDNA Fluorescent Test System

FDA UDI

by Immuno Concepts Inc

Identity

Trade Name
IgG Anti-nDNA Fluorescent Test System FDA UDI
Generic Name
Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay FDA UDI
Device Name
Custom - IgG anti-nDNA Fluorescent Bulk Pack - 350 Tests FDA UDI
Model / Reference
8287 FDA UDI
Description
Custom - IgG anti-nDNA Fluorescent Bulk Pack - 350 Tests FDA UDI

Identifiers

Catalog Number
8287 FDA UDI
Primary DI / UDI-DI
M7490082871 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

No

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

Yes

FDA UDI

Category: Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay

IgG Anti-nDNA Fluorescent Test System by Immuno Concepts 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
Immuno Concepts Inc

Sources (1)

  • FDA UDI ff136ce4-81fe-4231-850a-9bb9dd5025b5 34 fields · synced May 30, 2026