RIDASCREEN® Echinococcus IgG K7621

GUDID 04049095110511

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.

R-Biopharm AG

Echinococcus granulosus/E. multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 04049095110511
• NIH Device Record Key: da32e4d4-b481-4352-869d-a1460cc3c7aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIDASCREEN® Echinococcus IgG
• Version Model Number: K7621
• Catalog Number: K7621
• Company DUNS: 321850323
• Company Name: R-Biopharm AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049095110511 [Primary]

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-16
• Device Publish Date: 2019-05-08

Devices Manufactured by R-Biopharm AG

• 04049095260049 - RIDA® CCD-Inhibitor: 2023-07-11 The RIDA® CCD-Inhibitor is an accessory for use in in vitro diagnostics for the inhibition of anti-CCD IgE in human serum and p
• 04049095030079 - RIDASCREEN® Norovirus 3rd Generation: 2019-05-16 The RIDASCREEN® Norovirus 3rd Generation EIA test is a qualitative enzyme immunoassay (EIA) intended for the detection of selec
• 04049095110023 - RIDASCREEN® Entamoeba histolytica IgG: 2019-05-16 The RIDASCREEN® Entamoeba histolytica IgG test is an enzyme immunoassay for the qualitative determination of IgG antibodies aga
• 04049095110511 - RIDASCREEN® Echinococcus IgG: 2019-05-16The 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.
• 04049095110511 - RIDASCREEN® Echinococcus IgG: 2019-05-16 The RIDASCREEN® Echinococcus IgG test is an enzyme immunoassay for the qualitative determination of IgG antibodies against Echi
• 04049095110528 - RIDASCREEN® Taenia solium IgG: 2019-05-16 The RIDASCREEN® Taenia solium IgG test is an enzyme immunoassay for the qualitative determination of IgG antibodies against Tae
• 04049095160356 - RIDA®GENE Norovirus GI/GII: 2019-05-16 The RIDA®GENE Norovirus GI/GII assay, performed on the Applied Biosystems® 7500 Fast Dx System, is a real-time RT-PCR in vitro