E. HISTOLYTICA II

GUDID 00857031002349

The E. HISTOLYTICA II™ test is an enzyme immunoassay for the rapid detection of the adhesin of E. histolytica in human fecal specimens. It is indicated for use with fecal specimens from patients with diarrhea or dysentery to determine the presence of E. histolytica gastrointestinal infection. The test can be used for fecal specimens submitted for routine clinical testing from adults or children. Conventional microscopy is not a prerequisite for use of the test.

TECHLAB, INC.

Entamoeba histolytica antigen IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00857031002349
• NIH Device Record Key: 52dd7996-1b6f-4a29-bf02-bc396f675268
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E. HISTOLYTICA II
• Version Model Number: T5017
• 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	00857031002349 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K994101

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-23

On-Brand Devices [E. HISTOLYTICA II]

• 00857031002349: The E. HISTOLYTICA II™ test is an enzyme immunoassay for the rapid detection of the adhesin of
• 00857031002011: The E. HISTOLYTICA II™ test is an enzyme immunoassay for the rapid detection of the adhesin of