therascreen® FGFR RGQ RT-PCR Kit 874721

GUDID 04053228034094

The therascreen FGFR RGQ RT-PCR Kit is a real-time, reverse transcription PCR test for the qualitative detection of two point mutations in exon 7 [p.R248C (c.742C>T), p.S249C (c.746C>G)], two point mutations in exon 10 [p.G370C (c.1108G>T) and p.Y373C (c.1118A>G)] and two fusions (FGFR3:TACC3v1 and FGFR3:TACC3v3) in the fibroblast growth factor receptor 3 (FGFR3) gene in RNA samples derived from formalin-fixed paraffin-embedded (FFPE) urothelial tumor tissue. The test is indicated for use as an aid in identifying patients with cases of urothelial cancer (UC) which harbor these alterations and are therefore eligible for treatment with BALVERSA™ (erdafitinib). Specimens are processed using the RNeasy DSP FFPE Kit for manual sample preparation followed by reverse transcription and then automated amplification and detection on the Rotor-Gene Q MDx (US) instrument.

QIAGEN GmbH

Fibroblast growth factor receptor (FGFR) gene mutation IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 04053228034094
• NIH Device Record Key: 3feb004e-2717-48c3-8e3c-79278d0746b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: therascreen® FGFR RGQ RT-PCR Kit
• Version Model Number: V1
• Catalog Number: 874721
• Company DUNS: 317103745
• Company Name: QIAGEN GmbH
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-362-7737
• Email: techservice-na@qiagen.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04053228034094 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P180043

FDA Product Code

• OWD: Somatic Gene Mutation Detection System

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: 2019-05-07
• Device Publish Date: 2019-04-29

On-Brand Devices [therascreen® FGFR RGQ RT-PCR Kit]

• 04053228034094: The therascreen FGFR RGQ RT-PCR Kit is a real-time, reverse transcription PCR test for the quali
• 04053228043560: The therascreen FGFR RGQ RT-PCR Kit is a real-time, reverse transcription PCR test for the quali