C. DIFF CHEK - 60

GUDID 00857031002660

The C. DIFF CHEK™ - 60 test is an 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, this 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 patient history.

TECHLAB, INC.

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

• Primary Device ID: 00857031002660
• NIH Device Record Key: 1324a89e-ff43-47b0-bdcb-5e301b98bc37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C. DIFF CHEK - 60
• Version Model Number: TL5025
• 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	00857031002660 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030992

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: 2021-05-11
• Device Publish Date: 2021-05-03

On-Brand Devices [C. DIFF CHEK - 60]

• 00857031002233: The C. DIFF CHEK™ - 60 test is an enzyme immunoassay for use as a screening test to detect Clo
• 00857031002226: The C. DIFF CHEK™ - 60 test is an enzyme immunoassay for use as a screening test to detect Clo
• 00857031002110: The C. DIFF CHEK™ - 60 test is an enzyme immunoassay for use as a screening test to detect Clo
• 00857031002448: The C. DIFF CHEK™ - 60 test is an enzyme immunoassay for use as a screening test to detect Clo
• 00857031002660: The C. DIFF CHEK™ - 60 test is an enzyme immunoassay for use as a screening test to detect Clo