HEp-2000® Colorzyme® ANA-Ro Test System 4200-14-Ro

GUDID M749420014RO1

HEp-2000® ANA-Ro Colorzyme® Test System - 280 Tests

IMMUNO CONCEPTS INC

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

• Primary Device ID: M749420014RO1
• NIH Device Record Key: d65ef0b0-f33a-42bf-b556-0a2aea43ea8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEp-2000® Colorzyme® ANA-Ro Test System
• Version Model Number: 4200-14-Ro
• Catalog Number: 4200-14-Ro
• 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	M749420014RO1 [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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