Colorzyme® nDNA Test System 5200

GUDID M7490052001

nDNA CZ Test System - 280 Tests

IMMUNO CONCEPTS INC

Native DNA antibody (anti-nDNA) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: M7490052001
• NIH Device Record Key: aa897b7d-da5f-4511-a470-2ebe02f5ae04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Colorzyme® nDNA Test System
• Version Model Number: 5200
• Catalog Number: 5200
• 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	M7490052001 [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® nDNA Test System]

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• M7490083041: Custom - nDNA Colorzyme® Bulk Pack - 350 Tests
• M7490050401: nDNA CZ Test System - 70 Tests
• M7490050001: nDNA Colorzyme® Bulk Pack - 350 Tests
• M7490052001: nDNA CZ Test System - 280 Tests
• M7490050051: nDNA Colorzyme® Bulk Pack - 700 Tests