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 ID00857031002349
NIH Device Record Key52dd7996-1b6f-4a29-bf02-bc396f675268
Commercial Distribution StatusIn Commercial Distribution
Brand NameE. HISTOLYTICA II
Version Model NumberT5017
Company DUNS614218634
Company NameTECHLAB, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100857031002349 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KHWAntigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-23

On-Brand Devices [E. HISTOLYTICA II]

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

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