FDA.reportPublic FDA data

therascreen® PDGFRA RGQ PCR Kit

Primary DI
04053228034834
Brand
therascreen® PDGFRA RGQ PCR Kit
Company
QIAGEN GmbH
Model
1
Catalog number
874921
Device description
The QIAGEN therascreen® PDGFRA RGQ PCR Kit is a realtime qualitative in vitro diagnostic assay for the detection of the D842V somatic mutation in the PDGFRA gene using genomic DNA extracted from Gastrointestinal Stromal Tumor (GIST) patient’s formalin-fixed paraffin-embedded (FFPE) tumor tissue.The therascreen PDGFRA RGQ PCR Kit is intended for use as a companion diagnostic test, to aid clinicians in identification of patients with GIST who may be eligible for treatment with AYVAKIT™ (avapritinib) based on a PDGFRA mutation detected result. FFPE tumor specimens are processed using the QIAamp® DSP DNA FFPE Tissue Kit for manual sample preparation and the Rotor-Gene® Q (RGQ) MDx instrument for automated amplification and detection.
Published
2024-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OWDSomatic Gene Mutation Detection System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWDSomatic Gene Mutation Detection SystemUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P210002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P210002000therascreen PDGFRA RGQ PCR KitQIAGEN GmbH2023-06-29OWD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04053228034834PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053228034834040532280348344053228034834

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal cancer genotyping IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict gastrointestinal cancer [e.g., gastrointestinal stromal tumour (GIST)] based on multiple disease-associated genotypes, which may include KIT and PDGFRA gene mutations, using a nucleic acid technique (NAT).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-30 Degrees Celsius-15 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
800-362-7737techservice-na@qiagen.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
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04053228043850QIAstat-Dx® Meningitis/Encephalitis (ME) PanelV26916212025-10-31
04053228048381QIAstat-Dx® GI Panel 2 Mini BV16914232025-03-28
04053228049166QIAstat-Dx® GI Panel 2 Mini B&VV16914242025-02-18
04053228048862QIAstat-Dx® Respiratory Panel MiniV16912182024-12-05
04053228043249QIAstat-Dx® Gastrointestinal Panel 2V16914212024-06-17
14053228039409QIAstat-Dx® Respiratory Panel PlusV16912242025-09-25
04053228047438QIAstat-Dx® Respiratory Panel PlusV16912242024-06-17
04053228041849QIAstat-Dx® Rise190031632025-09-05
04053228040972CMV Primer ASRV111242602021-06-02
04053228040996CMV Probe ASRV111242642021-06-02
04053228048770QIAcuityDx® Four19110602024-09-30
04053228047582QIAstat-Dx Analyzer 2.0190028282024-09-18
04053228033936QIAstat-Dx® Analyzer 1.0v19002824 2019-05-24
04053228010838Rotor-Gene® Q MDx190020352016-09-24
04053228035725therascreen® BRAF RGQ PCR Kit18748212020-06-11
04053228049418QIAcuityDx® Universal MasterMix Kit1260101 2024-09-30
04053228049432QIAcuityDx® Universal MasterMix Kit12601022024-09-30
04053228033905QIAstat-Dx® Respiratory PanelV16912212019-05-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810022732571LeukoStratINVIVOSCRIBE, INC.OWD2023-05-30
04053228043560therascreen® FGFR RGQ RT-PCR KitQIAGEN GmbHOWD2022-05-23
00054749005505i-STATABBOTT POINT OF CARE INC.OWD2020-10-05
00875197005592cobas&#x00AE EZH2 Mutation TestRoche Molecular Systems, Inc.OWD2020-08-01
00054749005123i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005147i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005154i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005161i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005178i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005185i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005192i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005208i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005215i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005222i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
00054749005529i-STATABBOTT POINT OF CARE INC.OWD2020-07-01
04053228035725therascreen® BRAF RGQ PCR KitQIAGEN GmbHOWD2020-06-11
00850052003739LeukoStratINVIVOSCRIBE, INC.OWD2020-06-08
00850052003685LeukoStratINVIVOSCRIBE, INC.OWD2020-05-29
00054749005512i-STATABBOTT POINT OF CARE INC.OWD2020-05-01
00054749005093i-STATABBOTT POINT OF CARE INC.OWD2019-12-20
04053228034223therascreen® PIK3CA RGQ PCR KitQIAGEN GmbHOWD2019-06-05
04053228034094therascreen® FGFR RGQ RT-PCR KitQIAGEN GmbHOWD2019-04-29
00884999047792RealTimeABBOTT MOLECULAR INC.OWD2018-08-06
00884999047341RealTimeABBOTT MOLECULAR INC.OWD2018-07-30
00884999047358RealTimeABBOTT MOLECULAR INC.OWD2018-07-30
00884999047037RealTimeABBOTT MOLECULAR INC.OWD2017-08-11
00884999047044RealTimeABBOTT MOLECULAR INC.OWD2017-08-11
00884999047051RealTimeABBOTT MOLECULAR INC.OWD2017-08-11
03573026559823THxID™ BRAFBIOMERIEUX SAOWD2017-05-12
04053228002048therascreen® KRAS RGQ PCR KitQIAGEN GmbHOWD2017-01-04