QuickVue TLI Campylobacter Test

GUDID 00857031002578

The QuickVue TLI Campylobacter Test is a rapid membrane enzyme-linked immunosorbent assay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens. The QuickVue TLI Campylobacter Test is designed to detect C. jejuni and C. coli from patients with signs and symptoms of gastroenteritis. The test is intended for use with preserved fecal specimens in transport media and unpreserved fecal specimens. Test results should be considered in conjunction with clinical findings and patient history.

TECHLAB, INC.

Multiple Campylobacter species antigen IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00857031002578
• NIH Device Record Key: a2acc3a6-bcd4-482e-86bf-a5c60ae51a42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuickVue TLI Campylobacter Test
• Version Model Number: 20344
• Company DUNS: 614218634
• Company Name: TECHLAB, 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857031002578 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173217

FDA Product Code

• LQP: Campylobacter Spp.

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-07
• Device Publish Date: 2019-05-30

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