AUTO I.D.® SSA/Ro and SSB/La Autoantibody Test System 7001 (1)

GUDID M7490700111

AUTO I.D.® SSA Control - 1 x 0.5 ml

IMMUNO CONCEPTS INC

SSA/Ro antibody (Sjogren's antibody) IVD, control

• Primary Device ID: M7490700111
• NIH Device Record Key: 47117809-db96-445b-ab9b-032f3419fc7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AUTO I.D.® SSA/Ro and SSB/La Autoantibody Test System
• Version Model Number: 7001 (1)
• Catalog Number: 7001 (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	M7490700111 [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 [AUTO I.D.® SSA/Ro and SSB/La Autoantibody Test System]

• M749070021: Auto I.D.® SSA/SSB Control - 1 x 0.5 ml
• M7490700311: AUTO I.D.® Optional Control - SSB 1 x 0.5 ml
• M7490700111: AUTO I.D.® SSA Control - 1 x 0.5 ml
• M7490600411: AUTO I.D.® Optional Control - Jo-1 - 1 x 0.5 ml