FDA.reportPublic FDA data

artus® CMV RGQ MDx Kit

Primary DI
04053228002086
Brand
artus® CMV RGQ MDx Kit
Company
QIAGEN GmbH
Model
1
Catalog number
4503245
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
PABCytomegalovirus (Cmv) Dna Quantitative Assay

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PABCytomegalovirus (Cmv) Dna Quantitative AssayMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P130027000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P130027000ARTUS CMV RGQ MDX KITQiagen, Inc.2014-06-02PAB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04053228002086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053228002086040532280020864053228002086

GMDN Terms#

Term, Definition table
TermDefinition
Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from cytomegalovirus (CMV) in a clinical specimen, 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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04053228040576EZ2 Connect MDx900323090032302026-03-03
04053228039402QIAstat-Dx® Respiratory Panel PlusV16912242025-09-25
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
00884999051065Alinity mABBOTT MOLECULAR INC.PAB2024-02-22
15420045514553Aptima®Hologic, Inc.PAB2022-06-01
15420045514560Aptima®Hologic, Inc.PAB2022-06-01
15420045514577Aptima®Hologic, Inc.PAB2022-06-01
15420045514584Aptima®Hologic, Inc.PAB2022-06-01
00884999049598Alinity mABBOTT MOLECULAR INC.PAB2022-05-19
00884999049604Alinity mABBOTT MOLECULAR INC.PAB2022-05-19
00884999049611Alinity mABBOTT MOLECULAR INC.PAB2022-05-19
00884999049956Alinity mABBOTT MOLECULAR INC.PAB2022-05-19
00875197006421cobas® CMVRoche Molecular Systems, Inc.PAB2021-12-10
00875197006490cobas® CMV Control KitRoche Molecular Systems, Inc.PAB2021-12-10
04053228024538artus® CMV QS-RGQ MDx KitQIAGEN GmbHPAB2018-05-04
00875197004922cobas CMVRoche Molecular Systems, Inc.PAB2017-07-06
00875197004939cobas CMV Control KitRoche Molecular Systems, Inc.PAB2017-07-06
00884999045774RealTimeABBOTT MOLECULAR INC.PAB2017-06-06
00884999045781RealTimeABBOTT MOLECULAR INC.PAB2017-06-06
00884999045798RealTimeABBOTT MOLECULAR INC.PAB2017-06-06
00884999047297RealTimeABBOTT MOLECULAR INC.PAB2017-06-06
00884999046603RealTimeABBOTT MOLECULAR INC.PAB2017-04-17
00875197002584COBAS® AmpliPrep/ COBAS® TaqMan® CMV TestRoche Molecular Systems, Inc.PAB2014-09-10