RIDA®GENE Norovirus GI/GII PG1445

GUDID 04049095160356

The RIDA®GENE Norovirus GI/GII assay, performed on the Applied Biosystems® 7500 Fast Dx System, is a real-time RT-PCR in vitro diagnostic test for the qualitative detection and differentiation of norovirus genogroup I (GI) and II (GII) RNA from raw or unpreserved stool specimens collected from individuals with signs and symptoms of acute gastroenteritis.

R-Biopharm AG

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• Primary Device ID: 04049095160356
• NIH Device Record Key: 58c43060-8efb-4ece-98b0-3d888b1334ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIDA®GENE Norovirus GI/GII
• Version Model Number: PG1445
• Catalog Number: PG1445
• Company DUNS: 321850323
• Company Name: R-Biopharm AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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	04049095160356 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171511

FDA Product Code

• PIQ: Reagents For Detection Of Norovirus Nucleic Acid

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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• 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