FDA.reportPublic FDA data

QIAstat-Dx® Gastrointestinal Panel 2

Primary DI
04053228043249
Brand
QIAstat-Dx® Gastrointestinal Panel 2
Company
QIAGEN GmbH
Model
V1
Catalog number
691421
Device description
IVD kit containing 6 tests
Published
2024-06-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PCHGastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PCHGastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay SystemMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14053228043246PackageGS16In Commercial Distribution
04053228043249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1405322804324614053228043246
04053228043249040532280432494053228043249

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-type gastrointestinal pathogen 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 multiple types of microorganisms associated with gastrointestinal disease, in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include bacteria, viruses, fungi and/or parasites such as, but are not limited to Salmonella, Shigella, Campylobacter, Escherichia coli (E. coli), Norovirus, Rotavirus, Clostridium difficile, Giardia, Bacillus and/or Vibrio species.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Room temperature
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-426-8157xx@xx.xx

Regulatory Flags#

DUNS number
317103745
Device count
1
Kit
true
Lot or batch
true
Serial number
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
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
04053228034834therascreen® PDGFRA RGQ PCR Kit18749212024-12-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07332940009489XpertCEPHEIDPCH2026-01-30
30382904452798Enteric Bacterial Panel Diluent for BD COR™ SystemBECTON, DICKINSON AND COMPANYPCH2025-12-09
00382904448721BD Enteric Bacterial Panel plus for BD COR™ SystemBECTON, DICKINSON AND COMPANYPCH2025-12-09
00382904448738BD Enteric Bacterial Panel for BD COR™ SystemBECTON, DICKINSON AND COMPANYPCH2025-12-09
15420045517486Panther Fusion®Hologic, Inc.PCH2025-10-07
15420045517493Panther Fusion®Hologic, Inc.PCH2025-10-07
15420045517509Panther Fusion®Hologic, Inc.PCH2025-10-07
15420045517516Panther Fusion®Hologic, Inc.PCH2025-10-07
04053228048381QIAstat-Dx® GI Panel 2 Mini BQIAGEN GmbHPCH2025-03-28
00815381020888BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel MidBIOFIRE DIAGNOSTICS, LLCPCH2025-02-18
00815381020963BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel MidBIOFIRE DIAGNOSTICS, LLCPCH2025-02-18
04053228049166QIAstat-Dx® GI Panel 2 Mini B&VQIAGEN GmbHPCH2025-02-18
09351179004070EasyScreen™ Gastrointestinal Parasite PCR Positive ControlGENETIC SIGNATURES LIMITEDPCH2024-06-18
00382905168000BD Intelliport SystemBECTON, DICKINSON AND COMPANYPCH2024-06-07
00382904431594BD Pre-warm HeaterBECTON, DICKINSON AND COMPANYPCH2024-03-19
00382904439859BD MAX™ Enteric Viral PanelBECTON, DICKINSON AND COMPANYPCH2020-02-19
00840487101520Enteric Pathogens (EP) Nucleic Acid Test CartridgeLUMINEX CORPORATIONPCH2019-12-05
00840487101544Enteric Pathogens (EP) Amplification TrayLUMINEX CORPORATIONPCH2019-12-05
00840487101551Enteric Pathogens (EP) Extraction TrayLUMINEX CORPORATIONPCH2019-12-05
00840487101568Enteric Pathogens (EP) Stool Sample Preparation KitLUMINEX CORPORATIONPCH2019-12-05
00382904438128BD MAX™ Extended Enteric Bacterial PanelBECTON, DICKINSON AND COMPANYPCH2019-01-03
00851034007004BioCode MDx 3000APPLIED BIOCODE, INC.PCH2018-10-15
00851034007011Gastrointestinal Pathogen Panel (GPP) KitAPPLIED BIOCODE, INC.PCH2018-10-15
07332940000974Xpert NorovirusCEPHEIDPCH2018-01-29
B178GBSBPP100Stool Bacterial Pathogens PanelGREAT BASIN SCIENTIFIC, INC.PCH2017-07-24
00382904429607BD MAX™ Enteric Parasite PanelBECTON, DICKINSON AND COMPANYPCH2016-10-17
00382904429638BD MAX™ Enteric Bacterial PanelBECTON, DICKINSON AND COMPANYPCH2016-10-17
B178GBSTEC100Shiga Toxin Direct TestGREAT BASIN SCIENTIFIC, INC.PCH2016-09-23
00857573006041Enteric Pathogens (EP) Nucleic Acid Test CartridgeNANOSPHERE, INC.PCH2016-09-23
00857573006058Enteric Pathogens (EP) Extraction TrayNANOSPHERE, INC.PCH2016-09-23