Colorzyme® ANA Test System 4200

GUDID M7490042001

ANA Colorzyme® Test System - 260 Tests

IMMUNO CONCEPTS INC

Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: M7490042001
• NIH Device Record Key: 9e7eefbc-be21-475c-b361-5c66d533f8a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Colorzyme® ANA Test System
• Version Model Number: 4200
• Catalog Number: 4200
• 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	M7490042001 [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 [Colorzyme® ANA Test System]

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• M7490040401: ANA Colorzyme® Test System - 70 Tests
• M7490040001: ANA Colorzyme® Bulk Pack - 1300 Tests
• M7490042001: ANA Colorzyme® Test System - 260 Tests