FDA.reportPublic FDA data

Shiga Toxin Direct Test

Primary DI
B178GBSTEC102
Brand
Shiga Toxin Direct Test
Company
GREAT BASIN SCIENTIFIC, INC.
Model
GBSTEC-10
Catalog number
GBSTEC-10
Device description
Shiga Toxin Direct Test Cartridge with 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
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OOIReal Time Nucleic Acid Amplification System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B178GBSTEC102PackageHIBCC10In Commercial Distribution
B178GBSTEC100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple gastrointestinal pathogen nucleic acid IVD, kit, microarrayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types microorganisms associated with gastrointestinal disease, in a clinical specimen, using a microarray method. 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
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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
B178GBCDIFF100Portrait Toxigenic C. difficile AssayGBCDIFF-10GBCDIFF-102016-09-23
B178GBGBS100Group B Strep AssayGBGBS-10GBGBS-102016-09-23
B178SBPP102Stool Bacterial Pathogens PanelGBSBPP-10GBSBPP-102017-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850028489017MyrnaInflammatix, Inc.OOI2026-04-30
00850028489024TriVerityInflammatix, Inc.OOI2026-04-30
00875197005240cobas® Cdiff TestRoche Molecular Systems, Inc.OOI2026-02-24
00875197005288cobas® 4800 Cdiff Controls and Cofactor KitRoche Molecular Systems, Inc.OOI2026-02-24
00875197005677cobas® CdiffRoche Molecular Systems, Inc.OOI2026-02-23
00875197005684cobas® Cdiff Control KitRoche Molecular Systems, Inc.OOI2026-02-23
10816101025142LIAISON NES® InstrumentDIASORIN MOLECULAR LLCOOI2026-01-22
10816101025159LIAISON NES® Instrument (Refurbished)DIASORIN MOLECULAR LLCOOI2026-01-22
20816101029031LIAISON NES® FLU A/B, RSV & COVID-19DIASORIN MOLECULAR LLCOOI2026-01-22
20816101029048LIAISON NES® FLU A/B, RSV & COVID-19 Control Swab KitDIASORIN MOLECULAR LLCOOI2026-01-22
07332940009694GeneXpert®CEPHEIDOOI2026-01-19
07332940009700GeneXpert® XpressCEPHEIDOOI2026-01-19
20816101027358Simplexa COVID-19 / Flu A/B & RSV DirectDIASORIN MOLECULAR LLCOOI2026-01-14
20816101027365Simplexa COVID-19 / Flu A/B & RSV Positive Control PackDIASORIN MOLECULAR LLCOOI2026-01-14
30382904452798Enteric Bacterial Panel Diluent for BD COR™ SystemBECTON, DICKINSON AND COMPANYOOI2025-12-09
00382904448721BD Enteric Bacterial Panel plus for BD COR™ SystemBECTON, DICKINSON AND COMPANYOOI2025-12-09
00382904448738BD Enteric Bacterial Panel for BD COR™ SystemBECTON, DICKINSON AND COMPANYOOI2025-12-09
00382904452797Enteric Bacterial Panel Diluent for BD COR™ SystemBECTON, DICKINSON AND COMPANYOOI2025-12-09
06955792701717Q-Vera Prima 96 qPCR InstrumentSansure Biotech Inc.OOI2025-11-19
06955792701670Q-Vera Prima 96 qPCR InstrumentSansure Biotech Inc.OOI2025-10-16
15420045517486Panther Fusion®Hologic, Inc.OOI2025-10-07
15420045517493Panther Fusion®Hologic, Inc.OOI2025-10-07
15420045517509Panther Fusion®Hologic, Inc.OOI2025-10-07
15420045517516Panther Fusion®Hologic, Inc.OOI2025-10-07
06955792700857Q-Vera Pico 6X qPCR InstrumentSansure Biotech Inc.OOI2025-09-18
04053228041849QIAstat-Dx® RiseQIAGEN GmbHOOI2025-09-05
07332940009687GeneXpert®CEPHEIDOOI2025-08-15
00811877012153ID NOW InstrumentAlere Scarborough, Inc.OOI2025-08-01
10190302019859Diomni™ Software, Version 4.2.0LIFE TECHNOLOGIES HOLDINGS PTE. LTD.OOI2025-05-02
06973843220802careSTART™ Q1 AmplifierHangzhou Bioer Technology Co., Ltd.OOI2025-02-11