ANCA-L Test System 10350L-11

GUDID M74910350L111

ANCA-L BP FA Test System - Ethanol Fixed Substrate - 350 Tests

IMMUNO CONCEPTS INC

Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay

• Primary Device ID: M74910350L111
• NIH Device Record Key: dec1781f-302c-4f9c-a216-77636bc6c8e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANCA-L Test System
• Version Model Number: 10350L-11
• Catalog Number: 10350L-11
• 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	M74910350L111 [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

On-Brand Devices [ANCA-L Test System]

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• M74910700L111: ANCA-L BP FA Test System - Ethanol Fixed Substrate - 700 Tests
• M74910350L111: ANCA-L BP FA Test System - Ethanol Fixed Substrate - 350 Tests
• M74910140L111: ANCA-L FA Test System - Ethanol Fixed Substrate - 140 wells