ipsogen® JAK2 RGQ PCR Kit 673633

GUDID 04053228015444

QIAGEN GmbH

JAK2 V617F gene mutation IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 04053228015444
• NIH Device Record Key: fa80cd90-2364-441f-b62b-02e7b1f960d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ipsogen® JAK2 RGQ PCR Kit
• Version Model Number: V1
• Catalog Number: 673633
• 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	04053228015444 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN160028

FDA Product Code

• PSU: Jak2 Gene Mutation Detection Test

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: 2018-07-06
• Device Publish Date: 2017-05-22

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