ReQuest Q01-580

GUDID 00850487007043

Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

QUEST INTERNATIONAL, INC.

Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00850487007043
• NIH Device Record Key: aa720cba-e496-4de2-9575-bff06fe15314
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReQuest
• Version Model Number: Syphilis G
• Catalog Number: Q01-580
• 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	00850487007043 [Primary]

FDA Product Code

• LIP: Enzyme Linked Immunoabsorption Assay, Treponema Pallidum

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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