FDA.reportPublic FDA data

E. Histolytica IgG ELISA

Primary DI
00840239034748
Brand
E. Histolytica IgG ELISA
Company
DRG International Inc
Model
EIA-3474
Catalog number
EIA-3474
Device description
The E. histolytica ELISA test is a qualitative enzyme immunoassay for the detection of antibodies to E. histolytica, in samples of human serum or plasma.
Published
2019-03-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840239034748PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239034748008402390347488402390347480840239034748

GMDN Terms#

Term, Definition table
TermDefinition
Entamoeba histolytica immunoglobulin G (IgG) antibody 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 immunoglobulin G (IgG) antibodies to 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Total Volume1Milliliter
Total Volume11Milliliter
Total Volume25Milliliter
Total Volume30Milliliter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(973)564-7555corp@drg-international.com

Regulatory Flags#

DUNS number
075150847
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840239041173ANA Detect ELISAEIA-4117EIA-41172023-08-25
00840239035622ANA-8-Screen ELISAEIA-3562EIA-35622023-08-24
00840239035639ANA-8-Profile ELISAEIA-3563EIA-35632023-08-24
00840239027733ANA Screen IgG ELISA EIA-2773EIA-27732023-08-23
00840239035899Anti-Cardiolipin Screen ELISAEIA-3589EIA-35892023-08-25
00840239035967c-ANCA (PR3) ELISAEIA-3596EIA-35962023-08-25
00840239036025Anti-Lactoferrin ELISAEIA-3602EIA-36022023-08-25
00840239059673Measles Virus IgG Avidity ELISAEIA-5967EIA-59672023-08-26
00840239060594Giardia/Cryptosporidium Ag (stool) ELISA EIA-6059EIA-60592023-08-26
00840239027931Epstein Barr Virus VCA IgG ELISAEIA-2793EIA-27932023-08-24
00840239027948Epstein Barr Virus VCA IgM ELISAEIA-2794EIA-27942023-08-24
00840239027962EBV-EA IgG ELISAEIA-2796EIA-27962023-08-24
00840239028150H. Pylori IgG ELISA EIA-2815EIA-28152023-08-24
00840239033710Gliadin IgG ELISA EIA-3371EIA-33712023-08-24
00840239034670Cryptosporidium Antigen (stool) ELISA EIA-3467EIA-34672023-08-24
00840239034731Entamoeba histolytica Ag (stool) ELISA EIA-3473EIA-34732023-08-24
00840239034779Giardia lamblia Antigen (stool) ELISA EIA-3477EIA-34772023-08-24
00840239035523HGH (Human Growth Hormone) ELISAEIA-3552EIA-35522023-08-24
00840239035615Anti TPO Ab ELISAEIA-3561EIA-35612023-08-24
00840239035646Anti-dsDNA IgM ELISAEIA-3564EIA-35642023-08-24

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
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
00857031002011E. HISTOLYTICA IITECHLAB, INC.KHW2016-08-23
00857031002349E. HISTOLYTICA IITECHLAB, INC.KHW2016-08-23