ipsogen® JAK2 RGQ PCR Kit

Primary DI
04053228015444
Brand
ipsogen® JAK2 RGQ PCR Kit
Company
QIAGEN GmbH
Model
V1
Catalog number
673633
Published
2017-05-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PSUJak2 Gene Mutation Detection Test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PSUJak2 Gene Mutation Detection TestMedical Genetics2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN160028000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN160028000ipsogen JAK2 RGQ PCR KitQiagen, Inc.2017-03-27PSU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04053228015444PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053228015444040532280154444053228015444

GMDN Terms#

Term, Definition table
TermDefinition
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
317103745
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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