Ipsogen JAK2 RGQ PCR Kit

Jak2 Gene Mutation Detection Test

QIAGEN INC

The following data is part of a De Novo classification by Qiagen Inc with the FDA for Ipsogen Jak2 Rgq Pcr Kit.

Pre-market Notification Details

• DeNovo ID: DEN160028
• Device Name: Ipsogen JAK2 RGQ PCR Kit
• Classification: Jak2 Gene Mutation Detection Test
• Applicant: QIAGEN INC 19300 Germantown Road Germantown, MD 20874
• Contact: Lindsey Howard
• Product Code: PSU
• CFR Regulation Number: 866.6070 [🔎]
• Decision: Granted (DENG)
• 510(k) Premarket Notification: Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
• Review Advisory Board: Pathology
• Classification Advisory: Molecular Genetics
• Type: Direct
• Date Received: 2016-07-01
• Decision Date: 2017-03-27
• FDA Review: Decision Summary
• Reclassification Order: Reclassification Order

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04053228015444	DEN160028	000