RIDASCREEN® Entamoeba histolytica IgG

Primary DI
04049095110023
Brand
RIDASCREEN® Entamoeba histolytica IgG
Company
R-Biopharm AG
Model
K1721
Catalog number
K1721
Device description
The RIDASCREEN® Entamoeba histolytica IgG test is an enzyme immunoassay for the qualitative determination of IgG antibodies against Entamoeba histolytica in human serum. The test should be used for confirmation purposes when there is a suspected case of amoebiasis.
Published
2019-05-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049095110023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049095110023040490951100234049095110023

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
321850323
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049095070495RIDASCREEN® Pancreatic Elastase ELISAG09038USAG09038USA2026-03-26
04049095030079RIDASCREEN® Norovirus 3rd GenerationC1401USC1401US2019-05-08
04049095160356RIDA®GENE Norovirus GI/GIIPG1445PG14452019-05-08
04049095260049RIDA® CCD-InhibitorZA06012023-07-03
04049095110511RIDASCREEN® Echinococcus IgGK7621K76212019-05-08
04049095110528RIDASCREEN® Taenia solium IgGK7721K77212019-05-08