AUTO I.D.® Sm/RNP Autoantibody Test System 6001 (1)

GUDID M7490600111

AUTO I.D.® RNP Control - 1 x 0.5 ml

IMMUNO CONCEPTS INC

U1-RNP antibody IVD, control

• Primary Device ID: M7490600111
• NIH Device Record Key: e8f1dcea-0a21-4407-820d-199435ee6142
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AUTO I.D.® Sm/RNP Autoantibody Test System
• Version Model Number: 6001 (1)
• Catalog Number: 6001 (1)
• 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	M7490600111 [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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• M7497010101: AUTO I.D.® Plates - 10 x 6 Wells
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• M7490600111: AUTO I.D.® RNP Control - 1 x 0.5 ml