FDA.reportPublic FDA data

E. HISTOLYTICA II

Primary DI
00857031002011
Brand
E. HISTOLYTICA II
Company
TECHLAB, INC.
Model
30404
Device description
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 ofE. 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.
Published
2016-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KHWAntigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHWAntigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.Microbiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K994101000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K994101000E. HISTOLYTICA IITechlab, Inc.1999-12-21KHW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857031002011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857031002011008570310020118570310020110857031002011

GMDN Terms#

Term, Definition table
TermDefinition
Entamoeba histolytica antigen IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Entamoeba histolytica in a clinical specimen using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Entamoeba histolytica, the parasitic protozoan associated with amoebiasis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
614218634
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857031002547TRI-COMBO PARASITE SCREENT50322019-05-31
00857031002554C. DIFF QUIK CHEK COMPLETET50382019-05-31
00857031002073C. DIFFICILE TOX-B TEST30399U2020-01-24
00857031002530LEUKO EZ VUET50192020-01-24
00857031002561QuickVue TLI H. pylori Test203432019-05-30
00857031002226C. DIFF CHEK - 60T50252019-04-12
00857031002455CAMPYLOBACTER QUIK CHEKT50472019-04-12
00857031002301CRYPTOSPORIDIUM IIPT50142016-08-23
00857031002523H. PYLORI CHEK309962018-09-28
00857031002356LACTOFERRIN EZ VUET50182019-05-31
00857031002585QuickVue TLI Lactoferrin Test203452019-05-30
00857031002189LACTOFERRIN EZ VUE303532019-05-29
00857031002172LEUKO EZ VUET303552019-04-12
00857031002646C. DIFFICILE TOX A/B IIT5015XB2021-05-07
00857031002660C. DIFF CHEK - 60TL50252021-05-03
00857031002639H. PYLORI CHEK T5051B2021-03-12
00857031002066C. DIFFICILE TOXIN ANTITOXIN KITT50002020-01-24
00857031002264C. DIFFICILE TOX-B TESTT50032020-01-24
00857031002622QuickVue TLI H. pylori Stool Antigen Test203432019-09-26
00857031002196SHIGA TOXIN QUIK CHEKT306252019-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
ENTIENTG01400NovaLisa Entamoeba histolytica IgGGold Standard Diagnostics Frankfurt GmbHKHW2024-08-26
ENTIENTG0140NovaLisa Entamoeba histolytica IgGGold Standard Diagnostics Frankfurt GmbHKHW2024-08-26
00894175000282AccuDiag ™Diagnostic Automation, Inc.KHW2024-03-06
04048474038309Entamoeba histolytica IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungKHW2023-08-31
04048474034745Entamoeba histolytica IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungKHW2023-08-29
00840239038302Entamoeba histolytica IgG ELISADRG International IncKHW2023-08-25
B350GSD0130130Entamoeba histolytica IgG ELISA Test KitGold Standard Diagnostics CorporationKHW2022-11-18
07640158219652Fasciola hepatica IgG ELISA Bordier affinity products S.A.KHW2022-09-30
07640158219553Entamoeba histolytica IgG ELISA Bordier affinity products S.A.KHW2022-08-09
00083059070781E. histolytica ELISA [Enzyme-Linked ImmunoSorbent Assay]BIOMERICA, INC.KHW2020-07-01
00857031002547TRI-COMBO PARASITE SCREENTECHLAB, INC.KHW2019-05-31
00840239034748E. Histolytica IgG ELISADRG International IncKHW2019-03-20
00857031002400TRI-COMBO PARASITE SCREENTECHLAB, INC.KHW2017-10-05
00857031002202E. HISTOLYTICA QUIK CHEKTECHLAB, INC.KHW2017-09-15
08305900070781E. histolytica ELISA [Enzyme-Linked ImmunoSorbent Assay]BIOMERICA, INC.KHW2016-12-08
00857031002349E. HISTOLYTICA IITECHLAB, INC.KHW2016-08-23