RIDASCREEN® Entamoeba histolytica IgG K1721

GUDID 04049095110023

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.

R-Biopharm AG

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• Primary Device ID: 04049095110023
• NIH Device Record Key: 49466845-dd94-48b8-a06c-b6728b8c5009
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIDASCREEN® Entamoeba histolytica IgG
• Version Model Number: K1721
• Catalog Number: K1721
• 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	04049095110023 [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

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