GIARDIA II

GUDID 00857031002295

The GIARDIA II test is an enzyme immunoassay for the qualitative detection of Giardia lamblia cyst antigen in human fecal specimens. It is indicated for use with fecal specimens from patients with diarrhea to determine the presence of G. lamblia gastrointestinal infection. This test can be used for fecal specimens submitted for routine clinical testing from adults or children.

TECHLAB, INC.

Giardia lamblia antigen IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00857031002295
• NIH Device Record Key: e468ff67-a0c6-47c1-a18e-475b943c1a55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GIARDIA II
• Version Model Number: PT5012
• 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	00857031002295 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033274

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: 2016-08-23

On-Brand Devices [GIARDIA II]

• 00857031002295: The GIARDIA II test is an enzyme immunoassay for the qualitative detection of Giardia lamblia cy
• 00857031002028: The GIARDIA II test is an enzyme immunoassay for the qualitative detection of Giardia lamblia cy