therascreen® FGFR RGQ RT-PCR Kit

Basic Information

• Brand Name: therascreen® FGFR RGQ RT-PCR Kit
• Primary DI: 04053228043560
• Version / Model: 2
• Catalog Number: 874721
• Company Name: QIAGEN GmbH
• Labeler DUNS: 317103745
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-23
• Public Version: 1
• Public Version Date: 2022-05-31
• Public Version Status: New
• Public Device Record Key: 381c5fd1-573a-4414-91c3-8fa684e148f7

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OWD	Somatic Gene Mutation Detection System	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
63576	Fibroblast growth factor receptor (FGFR) gene mutation IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used to help select cancer treatment options and/or monitor the response to cancer therapy by determining the mutation status of the fibroblast growth factor receptor (FGFR) gene, using a using a nucleic acid technique (NAT). It is intended to be used to select urothelial cancer patients for pan-FGFR tyrosine kinase inhibitor (e.g., erdafitinib) therapy.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04053228043560	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P180043	001

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a constant temperature freezer. Protect from light.
• Type: Storage Environment Temperature
• Temperature Range: -90 – -15 Degrees Celsius