AccessGUDID - DEVICE: therascreen® FGFR RGQ RT-PCR Kit (04053228043560)

GUDID

Device Identifier (DI) Information

Brand Name: therascreen® FGFR RGQ RT-PCR Kit
Version or Model: 2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 874721
Company Name: QIAGEN GmbH

Primary DI Number: 04053228043560
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 317103745 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OWD	Somatic Gene Mutation Detection System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P180043	001

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in a constant temperature freezer. Protect from light.
Storage Environment Temperature: between -90 and -15 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 381c5fd1-573a-4414-91c3-8fa684e148f7
Public Version Date: May 31, 2022
Public Version Number: 1
DI Record Publish Date: May 23, 2022