therascreen® BRAF RGQ PCR Kit

Basic Information

• Brand Name: therascreen® BRAF RGQ PCR Kit
• Primary DI: 04053228035725
• Version / Model: 1
• Catalog Number: 874821
• Company Name: QIAGEN GmbH
• Labeler DUNS: 317103745
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-11
• Public Version: 1
• Public Version Date: 2020-06-19
• Public Version Status: New
• Public Device Record Key: 54bc712e-1d99-4f34-9ea7-4a30b0a8d7c3

Device Description

The therascreen BRAF V600E RGQ PCR Kit is a real-time PCR test for the qualitative detection of V600E mutations in the BRAF gene using genomic DNA extracted from formalin-fixed paraffin-embedded (FFPE) human colorectal cancer (CRC) tumor tissue. The therascreen BRAF V600E RGQ PCR Kit is an in vitro diagnostic device intended to be used as an aid in selecting patients with metastatic colorectal cancer (mCRC) whose tumors carry the BRAF V600E mutation for treatment with BRAFTOVI (encorafenib) in combination with cetuximab. The therascreen BRAF V600E RGQ PCR Kit is for use on the Rotor-Gene Q MDx (US) instrument. The therascreen BRAF V600E RGQ PCR Kit is intended for in vitro diagnostic use.

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
58276	BRAF V600 gene mutation IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used to select treatment options and/or monitor the response to cancer therapy by determining the V600 mutation status of the BRAF (v-raf murine sarcoma viral oncogene homolog B1) gene e.g., (V600A, V600D, V600E, V600K and V600R) in tumour tissue, using a nucleic acid technique (NAT).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04053228035725	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P190026	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -30 – -15 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Store in a constant temperature freezer. Protect from light.