C. DIFF QUIK CHEK

GUDID 00857031002141

The C. DIFF QUIK CHEK test is a rapid membrane enzyme immunoassay for use as a screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from persons suspected of having C. difficile disease. The test does not distinguish toxigenic from nontoxigenic strains of C. difficile. With the use of additional tests that detect C. difficile toxins, the test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction with the patient history.

TECHLAB, INC.

Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00857031002141
• NIH Device Record Key: f89feb4d-4048-404b-8ccc-672b7d10261d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C. DIFF QUIK CHEK
• Version Model Number: 30390
• 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	00857031002141 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053572

FDA Product Code

• MCB: Antigen, C. Difficile

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: 2018-10-29
• Device Publish Date: 2018-09-28

Devices Manufactured by TECHLAB, INC.

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• 00857031002622 - QuickVue TLI H. pylori Stool Antigen Test: 2019-10-04 The QuickVue TLI H. pylori Stool Antigen Test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobact