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Fluorescent ANA Test System

FDA UDI

by Immuno Concepts Inc

Identity

Trade Name
Fluorescent ANA Test System FDA UDI
Generic Name
Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay FDA UDI
Device Name
Custom - ANA FA Slides Only - 650 x 13 Well FDA UDI
Model / Reference
8060 FDA UDI
Description
Custom - ANA FA Slides Only - 650 x 13 Well FDA UDI

Identifiers

Catalog Number
8060 FDA UDI
Primary DI / UDI-DI
M7490080601 FDA UDI
GMDN Term
Multiple antinuclear antibody (ANA) screening 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: Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay

Fluorescent ANA Test System by Immuno Concepts Inc — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple antinuclear antibody (ANA) screening 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 51b8c991-96da-4445-9c9b-2b6d68bf93bb 34 fields · synced May 30, 2026