AUTO I.D.® Sm/RNP Autoantibody Test System 6050 (1)

GUDID M7490605011

AUTO I.D.® Universal Antigen - 1 x 0.2 ml

IMMUNO CONCEPTS INC

Multiple extractable nuclear antigen (ENA) IVD, control

• Primary Device ID: M7490605011
• NIH Device Record Key: 286c1ba5-e889-473a-b66f-b0128ead7443
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AUTO I.D.® Sm/RNP Autoantibody Test System
• Version Model Number: 6050 (1)
• Catalog Number: 6050 (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	M7490605011 [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: 2019-11-08
• Device Publish Date: 2016-09-24

On-Brand Devices [AUTO I.D.® Sm/RNP Autoantibody Test System]

• M7490605011: AUTO I.D.® Universal Antigen - 1 x 0.2 ml
• M7490600511: AUTO I.D.® Optional Control - Scl-70 - 1 x 0.5 ml
• M7490600611: AUTO I.D.® Optional Control - PCNA/Cyclin - 1 x 0.5 ml
• M7490060601: AUTO I.D.® Sm/RNP Autoantibody - 60 Test System (72 wells)
• M7497010101: AUTO I.D.® Plates - 10 x 6 Wells
• M7490600211: AUTO I.D.® Sm/RNP Control - 1 x 0.5 ml
• M7490600111: AUTO I.D.® RNP Control - 1 x 0.5 ml