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Histofluor® Rodent LKS Fluorescent Antibody Test System

FDA UDI

by Immuno Concepts Inc

Identity

Trade Name
Histofluor® Rodent LKS Fluorescent Antibody Test System FDA UDI
Generic Name
Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay FDA UDI
Device Name
Rat LKS Tissue Kit - 800 tests FDA UDI
Model / Reference
8289 FDA UDI
Description
Rat LKS Tissue Kit - 800 tests FDA UDI

Identifiers

Catalog Number
8289 FDA UDI
Primary DI / UDI-DI
M7490082891 FDA UDI
GMDN Term
Intrinsic factor/parietal cell antibody 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 immunoassayMitochondrial antibody M2 (anti-Mi2) IVD, kit, fluorescent immunoassaySmooth muscle antibody IVD, kit, fluorescent immunoassayIntrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay

Histofluor® Rodent LKS Fluorescent Antibody Test System by Immuno Concepts Inc — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Liver-kidney microsome 1 antibody (anti-LKM1) 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 3b0812b9-58de-4e77-9b0c-6522603f5bc0 34 fields · synced Jun 8, 2026