FDA.reportPublic FDA data

therascreen® KRAS RGQ PCR Kit

Primary DI
04053228002048
Brand
therascreen® KRAS RGQ PCR Kit
Company
QIAGEN GmbH
Model
1
Catalog number
870021
Published
2017-01-04
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
OWDSomatic Gene Mutation Detection System

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04053228002048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053228002048040532280020484053228002048

GMDN Terms#

Term, Definition table
TermDefinition
KRAS gene mutation IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative detection of the KRAS (v-ki-ras2 kirsten rat sarcoma viral oncogene homolog) mutation status and/or to evaluate a clinical specimen to predict or monitor the response to treatment with epidermal growth factor receptor (EGFR) inhibitors by determining the KRAS mutation status of tumour tissue using a nucleic acid technique (NAT).

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

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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
04053228034834therascreen® PDGFRA RGQ PCR KitQIAGEN GmbHOWD2024-12-10
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