SHIGA TOXIN QUIK CHEK

GUDID 00857031002196

The SHIGA TOXIN QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the simultaneous qualitative detection and differentiation of Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in a single test device. It is intended for use with human fecal samples from patients with gastrointestinal symptoms to aid in the diagnosis of disease caused by Shiga toxin producing Escherichia coli (STEC). It may be used with fecal specimens, or broth or plate cultures derived from fecal specimens. The test results should be considered in conjunction with the patient history.

TECHLAB, INC.

Escherichia coli antigen IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00857031002196
• NIH Device Record Key: fbad0d88-bc7b-4c28-b12c-ed9657e57a3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SHIGA TOXIN QUIK CHEK
• Version Model Number: T30625
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857031002196 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121364

FDA Product Code

• GMZ: Antigens, All Types, Escherichia Coli

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: 2019-08-14
• Device Publish Date: 2019-08-06

Devices Manufactured by TECHLAB, INC.

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