ReQuest 01-280

GUDID 00850487007296

Jo-1 antibody IVD, kit, enzyme immunoassay (EIA)

QUEST INTERNATIONAL, INC.

Jo-1 antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00850487007296
• NIH Device Record Key: b4042547-ebee-44b0-835d-4782179f05e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReQuest
• Version Model Number: Anti Jo1
• Catalog Number: 01-280
• Company DUNS: 883350811
• Company Name: QUEST INTERNATIONAL, 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850487007296 [Primary]

FDA Product Code

• LJM: Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-31

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