therascreen® BRAF RGQ PCR Kit 874821

GUDID 04053228035725

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.

QIAGEN GmbH

BRAF gene mutation IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 04053228035725
• NIH Device Record Key: 54bc712e-1d99-4f34-9ea7-4a30b0a8d7c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: therascreen® BRAF RGQ PCR Kit
• Version Model Number: 1
• Catalog Number: 874821
• 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
• Phone: 800-362-7737
• Email: techservice-na@qiagen.com
• Phone: 800-362-7737
• Email: techservice-na@qiagen.com
• Phone: 800-362-7737
• Email: techservice-na@qiagen.com
• Phone: 800-362-7737
• Email: techservice-na@qiagen.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a constant temperature freezer. Protect from light.
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a constant temperature freezer. Protect from light.
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a constant temperature freezer. Protect from light.
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a constant temperature freezer. Protect from light.
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a constant temperature freezer. Protect from light.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04053228035725 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P190026

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-06-09
• Device Publish Date: 2020-06-11

Devices Manufactured by QIAGEN GmbH

• 04053228035725 - therascreen® BRAF RGQ PCR Kit: 2025-06-09The 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.
• 04053228035725 - therascreen® BRAF RGQ PCR Kit: 2025-06-09 The therascreen BRAF V600E RGQ PCR Kit is a real-time PCR test for the qualitative detection of V600E mutations in the BRAF gene
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