Histofluor® Rodent LKS Fluorescent Antibody Test System 12022-02R (1)

GUDID M7491202202R11

APCA Optional Positive Control 1 x 0.5 ml

IMMUNO CONCEPTS INC

Parietal cell antibody IVD, control

• Primary Device ID: M7491202202R11
• NIH Device Record Key: 87a4dd10-31e1-4693-b296-0d05343aa43b
• Commercial Distribution Discontinuation: 2019-11-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Histofluor® Rodent LKS Fluorescent Antibody Test System
• Version Model Number: 12022-02R (1)
• Catalog Number: 12022-02R (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	M7491202202R11 [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: 2016-09-24

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• 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
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• M7491226302R11: ASMA Titratable Control 1 x 0.25 ml
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• M74912160021: Mouse LKS Tissue FA Test System- 160 tests
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• 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.
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• 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