HEp-2000® IgG Fluorescent w/cs ANA-Ro Test System 2280B-Ro

GUDID M7492280BRO1

HEp-2000® IgG FA w/cs ANA-Ro Test System - 280 Tests

IMMUNO CONCEPTS INC

Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay

• Primary Device ID: M7492280BRO1
• NIH Device Record Key: cbc12cec-8234-4bb2-8414-8792d712ac67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEp-2000® IgG Fluorescent w/cs ANA-Ro Test System
• Version Model Number: 2280B-Ro
• Catalog Number: 2280B-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	M7492280BRO1 [Primary]

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-06
• Device Publish Date: 2021-04-28

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