GIARDIA/CRYPTOSPORIDIUM QUIK CHEK

GUDID 00857031002165

The GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the simultaneous qualitative detection and differentiation of Giardia cyst antigen and Cryptosporidium oocyst antigen in a single test device. It is intended for use with human fecal specimens from patients with gastrointestinal symptoms to aid in the diagnosis of Giardia and/or Cryptosporidium gastrointestinal infection. The test results should be considered in conjunction with the patient history.

TECHLAB, INC.

Multiple faecal parasite antigen IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00857031002165
• NIH Device Record Key: c46211fa-6701-479d-9f37-b25c1abbf9d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GIARDIA/CRYPTOSPORIDIUM QUIK CHEK
• Version Model Number: T30407
• 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	00857031002165 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103673

FDA Product Code

• MHI: Giardia Spp.

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-20

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