FDA.reportPublic FDA data

Portrait Toxigenic C. difficile Assay

Primary DI
B178GBCDIFF100
Brand
Portrait Toxigenic C. difficile Assay
Company
GREAT BASIN SCIENTIFIC, INC.
Model
GBCDIFF-10
Catalog number
GBCDIFF-10
Device description
C. diff Assay Cartridge and Sample Prep Device.
Published
2016-09-23
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
OMNC. Difficile Nucleic Acid Amplification Test Assay
OZNC.Difficile Toxin Gene Amplification Assay

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMNC. Difficile Nucleic Acid Amplification Test AssayMicrobiology1
OZNC. Difficile Toxin Gene Amplification AssayMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B178GBCDIFF102PackageHIBCC10In Commercial Distribution
B178GBCDIFF100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Clostridium difficile toxin B 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 which encodes for toxin B production from Clostridium difficile bacteria in a clinical specimen, using a nucleic acid technique (NAT).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(888) 333-9763customersupport@gbscience.com

Regulatory Flags#

DUNS number
827115259
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B178PA5000PA500 Portrait AnalyzerPA500PA5002016-09-23
B178GBSBPP100Stool Bacterial Pathogens PanelGBSBPP-10GBSBPP-102017-07-24
B178GBSTEC100Shiga Toxin Direct TestGBSTEC-10GBSTEC-102016-09-23
B178GBSIDR100Staph ID/R Blood Culture PanelGBSIDR-10GBSIDR-102016-09-23
B178GBSIDR102Staph ID/R Blood Culture PanelGBSIDR-10GBSIDR-102016-09-23
B178GBBORD100Bordetella Direct TestGBBORD-10GBBORD-102017-07-12
B178GBGBS100Group B Strep AssayGBGBS-10GBGBS-102016-09-23
B178SBPP102Stool Bacterial Pathogens PanelGBSBPP-10GBSBPP-102017-07-24
B178GBSTEC102Shiga Toxin Direct TestGBSTEC-10GBSTEC-102016-09-23

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
00840733102134Alethia™ C. difficile External Control KitMERIDIAN BIOSCIENCE, INC.OMN2019-01-09
00840733102172Alethia™ C. difficileMERIDIAN BIOSCIENCE, INC.OMN2019-01-09
30014613336150SolanaDIAGNOSTIC HYBRIDS, INC.OZN2018-07-20
07332940000028Xpert C. difficile/EpiCEPHEIDOMN2018-01-29
07332940000042Xpert C. difficile/EpiCEPHEIDOMN2018-01-29
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
04053228004646artus® C. difficile QS-RGQ MDx KitQIAGEN GmbHOZN2017-01-04
00840733101120illumigene C. difficile External Control KitMERIDIAN BIOSCIENCE, INC.OMN2016-09-23
00840733101168illumigene C. difficileMERIDIAN BIOSCIENCE, INC.OMN2016-09-23
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
20816101025583Simplexa™ C. difficile Universal DirectDIASORIN MOLECULAR LLCOMN2016-09-22
30014613311058LyraQUIDEL CORPORATIONOZN2016-09-15
30014613312017AmpliVueQUIDEL CORPORATIONOZN2016-09-15
00382904419165BD MAX™ SystemBECTON, DICKINSON AND COMPANYOZN2016-05-19