FDA.reportPublic FDA data

artus® C. difficile QS-RGQ MDx Kit

Primary DI
04053228004646
Brand
artus® C. difficile QS-RGQ MDx Kit
Company
QIAGEN GmbH
Model
1
Catalog number
4572346
Published
2017-01-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OZNC.Difficile Toxin Gene Amplification Assay

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OZNC. Difficile Toxin Gene Amplification AssayMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04053228004646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053228004646040532280046464053228004646

GMDN Terms#

Term, Definition table
TermDefinition
Clostridium difficile 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, including specific gene markers from Clostridium difficile bacteria in a clinical specimen and/or culture isolate, using a nucleic acid technique (NAT). Markers detected may include genes conferring antimicrobial resistance (e.g., gyrA gene), virulence (e.g., ribotype 027) and genes encoding toxin A and/or B.

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
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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
G491CDF20Toxigenic C. difficile Direct TestVela Operations USA Inc.OZN2024-01-18
G491CDF21Toxigenic C. difficile Direct TestVela Operations USA Inc.OZN2024-01-18
G491CDF2SPD0Toxigenic C. difficile Direct Test - Sample PrepVela Operations USA Inc.OZN2024-01-18
00840733102349Revogene C. difficileMERIDIAN BIOSCIENCE, INC.OZN2020-07-15
00840487101605Clostridium difficile (CDF) Nucleic Acid Test CartridgeLUMINEX CORPORATIONOZN2019-12-05
00840487101650Clostridium difficile (CDF) Extraction TrayLUMINEX CORPORATIONOZN2019-12-05
00840487101704Clostridium difficile (CDF) Amplification TrayLUMINEX CORPORATIONOZN2019-12-05
00840487101735Clostridium difficile (CDF) Stool Sample Preparation KitLUMINEX CORPORATIONOZN2019-12-05
00628055344124Revogene® C. difficileMeridian Bioscience Canada IncOZN2019-10-21
30014613336150SolanaDIAGNOSTIC HYBRIDS, INC.OZN2018-07-20
00628055344025GenePOC™ CDiff GenePoc IncOZN2017-12-29
00840487100059ARIES® C. difficile AssayLUMINEX CORPORATIONOZN2017-07-25
20816101025590Simplexa™ C. difficile DirectDIASORIN MOLECULAR LLCOZN2017-02-16
20816101025606Simplexa™ C. difficile Positive Control PackDIASORIN MOLECULAR LLCOZN2017-02-16
20816101025613Simplexa™ C.difficile Sample Prep KitDIASORIN MOLECULAR LLCOZN2017-02-16
B178GBCDIFF100Portrait Toxigenic C. difficile AssayGREAT BASIN SCIENTIFIC, INC.OZN2016-09-23
00857573006157Clostridium difficile (CDF) Nucleic Acid Test CartridgeNANOSPHERE, INC.OZN2016-09-23
00857573006256Clostridium difficile (CDF) Extraction TrayNANOSPHERE, INC.OZN2016-09-23
00857573006317Clostridium difficile (CDF) Amplification TrayNANOSPHERE, INC.OZN2016-09-23
00857573006362Clostridium difficile (CDF) Stool Sample Preparation KitNANOSPHERE, INC.OZN2016-09-23
30014613311058LyraQUIDEL CORPORATIONOZN2016-09-15
30014613312017AmpliVueQUIDEL CORPORATIONOZN2016-09-15
00382904419165BD MAX™ SystemBECTON, DICKINSON AND COMPANYOZN2016-05-19
00382904434182BD MAX™ Cdiff (US)BECTON, DICKINSON AND COMPANYOZN2016-05-19