therascreen® PDGFRA RGQ PCR Kit

Basic Information

• Brand Name: therascreen® PDGFRA RGQ PCR Kit
• Primary DI: 04053228034834
• Version / Model: 1
• Catalog Number: 874921
• Company Name: QIAGEN GmbH
• Labeler DUNS: 317103745
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-10
• Public Version: 1
• Public Version Date: 2024-12-18
• Public Version Status: New
• Public Device Record Key: 4a9cbfa9-32e6-4608-8acd-9f3c0974beb5

Device Description

The QIAGEN therascreen® PDGFRA RGQ PCR Kit is a realtime qualitative in vitro diagnostic assay for the detection of the D842V somatic mutation in the PDGFRA gene using genomic DNA extracted from Gastrointestinal Stromal Tumor (GIST) patient’s formalin-fixed paraffin-embedded (FFPE) tumor tissue. The therascreen PDGFRA RGQ PCR Kit is intended for use as a companion diagnostic test, to aid clinicians in identification of patients with GIST who may be eligible for treatment with AYVAKIT™ (avapritinib) based on a PDGFRA mutation detected result. FFPE tumor specimens are processed using the QIAamp® DSP DNA FFPE Tissue Kit for manual sample preparation and the Rotor-Gene® Q (RGQ) MDx instrument for automated amplification and detection.

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
63195	Gastrointestinal cancer genotyping IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict gastrointestinal cancer [e.g., gastrointestinal stromal tumour (GIST)] based on multiple disease-associated genotypes, which may include KIT and PDGFRA gene mutations, using a nucleic acid technique (NAT).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04053228034834	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P210002	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -30 – -15 Degrees Celsius