TRI-COMBO PARASITE SCREEN

GUDID 00857031002547

The TECHLAB® TRl-COMBO PARASITE SCREEN test is an enzyme immunoassay for the simultaneous qualitative detection of Giardia spp., Cryptosporidium spp. and/or E. histolytica antigen in human fecal specimens. The test is indicated as an aid in the diagnosis of gastrointestinal infection when giardiasis, cryptosporidiosis and amebiasis is suspected. The test does not differentiate between the three parasites and follow-up testing is required for all positive results to confirm the specific diagnosis.

TECHLAB, INC.

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

• Primary Device ID: 00857031002547
• NIH Device Record Key: 53648e1b-3105-4d20-b673-c7096d0ca3b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRI-COMBO PARASITE SCREEN
• Version Model Number: T5032
• 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: false
• 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	00857031002547 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171078

FDA Product Code

• KHW: Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.

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: 2019-06-10
• Device Publish Date: 2019-05-31

On-Brand Devices [TRI-COMBO PARASITE SCREEN]

• 00857031002400: The TECHLAB® TRl-COMBO PARASITE SCREEN test is an enzyme immunoassay for the simultaneous quali
• 00857031002547: The TECHLAB® TRl-COMBO PARASITE SCREEN test is an enzyme immunoassay for the simultaneous quali