RIDASCREEN® Echinococcus IgG

Primary DI
04049095110511
Brand
RIDASCREEN® Echinococcus IgG
Company
R-Biopharm AG
Model
K7621
Catalog number
K7621
Device description
The RIDASCREEN® Echinococcus IgG test is an enzyme immunoassay for the qualitative determination of IgG antibodies against Echinococcus granulosus und Echinococcus multilocularis in human serum. The test should be used for confirmation purposes when there is a suspected case of infection with Echinococcus.
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
04049095110511PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049095110511040490951105114049095110511

GMDN Terms#

Term, Definition table
TermDefinition
Echinococcus granulosus/E. multilocularis 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 Echinococcus granulosus and/or Echinococcus multilocularis in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with the parasitic tapeworms associated with hydatid disease.

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

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