C. DIFF QUIK CHEK COMPLETE

GUDID 00857031002387

The C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoassay for the simultaneous detection of Clostridium difficile glutamate dehydrogenase antigen and toxins A and B in a single reaction well. The test detects C. difficile antigen, glutamate dehydrogenase, as a screen for the presence of C. difficile and confirms the presence of toxigenic C. difficile by detecting toxins A and B in fecal specimens from persons suspected of having C. difficile disease. 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: 00857031002387
• NIH Device Record Key: ae7254bc-2c7a-4663-9387-3cd0bdbcff60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C. DIFF QUIK CHEK COMPLETE
• Version Model Number: 30550C
• 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	00857031002387 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082499

FDA Product Code

• LLH: Reagents, Clostridium Difficile Toxin

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: 2018-09-07
• Device Publish Date: 2018-08-07

On-Brand Devices [C. DIFF QUIK CHEK COMPLETE]

• 00857031002387: The C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoassay for the simultaneou
• 00857031002370: The C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoassay for the simultaneou
• 00857031002158: The TECHLAB® C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoassay for the s
• 00857031002059: The TECHLAB® C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoassay for the s
• 00857031002554: The TECHLAB® C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoassay for the s