Histofluor® Rodent LKS Fluorescent Antibody Test System 12261-02 (1)

GUDID M749122610211

AMA Titratable Control 1 x 0.25 ml

IMMUNO CONCEPTS INC

Mitochondrial antibody M2 (anti-Mi2) IVD, control

• Primary Device ID: M749122610211
• NIH Device Record Key: 31676dde-d83f-4f51-90c4-5e5f44b7c3db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Histofluor® Rodent LKS Fluorescent Antibody Test System
• Version Model Number: 12261-02 (1)
• Catalog Number: 12261-02 (1)
• Company DUNS: 038271904
• Company Name: IMMUNO CONCEPTS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M749122610211 [Primary]

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-14
• Device Publish Date: 2016-10-07

On-Brand Devices [Histofluor® Rodent LKS Fluorescent Antibody Test System ]

• M74912040031: Rat LKS Tissue FA Test System - 40 tests
• M7491200804101: Mouse KS 8 Well Tissue Slides - 10 Slides
• M7491200803101: Rat LKS 8 Well Tissue Slides - 10 Slides
• M7491216002R1: Mouse LKS Tissue FA Test System - RUO - 160 Tests
• M74912160041: Mouse KS Tissue FA Test System- 160 tests
• M74912040051: Rat KS Tissue FA Test System - 40 tests
• M7491203111: Negative Control 1 x 1ml
• M749120220211: APCA Optional Positive Control 1 x 0.5 ml
• M7491200802101: Mouse LKS 8 Well Tissue Slides - 10 Slides
• M7491200405101: Rat KS 4 Well Tiissue Slides - 10 Slides
• M7491200403101: Rat LKS 4 Well Tiissue Slides - 10 Slides
• M74912800031: Rat LKS Tissue FA Test System - 800 tests
• M74912400021: Mouse LKS Tissue Kit - 400 tests
• M7491226302R11: ASMA Titratable Control 1 x 0.25 ml
• M749122630211: ASMA Titratable Control - 1 x 0.25 ml
• M74912160021: Mouse LKS Tissue FA Test System- 160 tests
• M74912080021: Histofluor® Mouse LKS FA Tissue Kit - 80 Tests
• M74912040041: Mouse KS Tissue FA Test System - 40 tests
• M7491202302R11: ASMA Optional Positive Control - 1 x 0.5 ml
• M749120230211: ASMA Optional Positive Control - 1 x 0.5 ml
• M749120090211: Rodent Tissue IgG Fluorescent Antibody Reagent 1 x 9ml.
• M7490082891: Rat LKS Tissue Kit - 800 tests
• M74912800021: Mouse LKS Tissue FA Test System - 800 tests
• M74912400041: Mouse KS Tissue Kit - 400 Tests
• M749122620211: APCA Titratable Control 1 x 0.25 ml
• M7491226102R11: AMA Titratable Control - 1 x 0.25 ml
• M749122610211: AMA Titratable Control 1 x 0.25 ml
• M74912160051: Rat KS Tissue FA Test System- 160 tests
• M7491216004R1: Mouse KS Tissue FA Test System - RUO - 160 tests
• M74912160031: Rat LKS Tissue FA Test System- 160 tests
• M7491204004R1: Mouse KS Tissue FA Test System - RUO - 40 tests
• M74912040021: Mouse LKS Tissue FA Test System - 40 Tests
• M7491202202R11: APCA Optional Positive Control 1 x 0.5 ml
• M7491200805101: Rat KS 8 Well Tissue Slides - 10 Slides
• M7491200404101: Mouse KS 4 Well Tissue Slides - 10 Slides
• M7491200402101: Mouse LKS 4 Well Tiissue Slides - 10 Slides
• M7491208031: Histofluor® Rat LKS FA Tissue Kit - 80 Tests
• M749120750211: Rodent Tissue IgG Fluorescent Antibody Reagent 1 x 23ml.
• M749120210211: AMA Positive Control 1 x 1.0 ml