therascreen® KRAS RGQ PCR Kit 870021

GUDID 04053228002048

QIAGEN GmbH

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

• Primary Device ID: 04053228002048
• NIH Device Record Key: 0183de6f-edfd-418d-8380-66845fdbd810
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: therascreen® KRAS RGQ PCR Kit
• Version Model Number: 1
• Catalog Number: 870021
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04053228002048 [Primary]

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: 3
• Public Version Date: 2020-05-06
• Device Publish Date: 2017-01-04

Devices Manufactured by QIAGEN GmbH

• 04053228030072 - QIAsymphony® DSP Circulating DNA Kit: 2022-12-15
• 04053228031024 - RNeasy® DSP FFPE Kit: 2022-12-15
• 04053228045762 - QIAsymphony® DSP DNA Midi Kit: 2022-12-15
• 04053228045779 - QIAsymphony® DSP DNA Mini Kit: 2022-12-15
• 04053228045786 - QIAsymphony® DSP Virus/Pathogen Midi Kit: 2022-12-15
• 04053228045793 - QIAsymphony® DSP Virus/Pathogen Mini Kit: 2022-12-15
• 04053228045809 - EZ1® DSP Virus Kit: 2022-12-15
• 04053228045816 - EZ1® DSP DNA Blood Kit: 2022-12-15