ipsogen® JAK2 RGQ PCR Kit

Basic Information

• Brand Name: ipsogen® JAK2 RGQ PCR Kit
• Primary DI: 04053228015444
• Version / Model: V1
• Catalog Number: 673633
• Company Name: QIAGEN GmbH
• Labeler DUNS: 317103745
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-22
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: fa80cd90-2364-441f-b62b-02e7b1f960d9

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
PSU	Jak2 Gene Mutation Detection Test	Medical Genetics	866.6070	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60671	JAK2 V617F gene mutation IVD, kit, nucleic acid technique (NAT)	A collection of reagents or other associated materials intended to be used to detect or monitor the V617F mutation in the Janus kinase 2 (JAK2) gene in a clinical specimen, using a nucleic acid technique (NAT). This mutation is associated with haematological abnormalities that may include essential thrombocythemia, polycythemia vera, primary myelofibrosis or leukaemia.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04053228015444	GS1

Premarket Submissions

Submission Number	Supplement Number
DEN160028	000