Colorzyme® ANA Test System 4000

GUDID M7490040001

ANA Colorzyme® Bulk Pack - 1300 Tests

IMMUNO CONCEPTS INC

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

• Primary Device ID: M7490040001
• NIH Device Record Key: 12b44157-a0df-4b4b-8b57-266d505e124f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Colorzyme® ANA Test System
• Version Model Number: 4000
• Catalog Number: 4000
• 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	M7490040001 [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: 2019-11-13
• Device Publish Date: 2016-09-24

On-Brand Devices [Colorzyme® ANA Test System]

• M7490407511: ANA IgG Enzyme Antibody Reagent 1 x 23 mls.
• M7490040401: ANA Colorzyme® Test System - 70 Tests
• M7490040001: ANA Colorzyme® Bulk Pack - 1300 Tests
• M7490042001: ANA Colorzyme® Test System - 260 Tests