FDA.reportPublic FDA data

Stool Bacterial Pathogens Panel

Primary DI
B178GBSBPP100
Brand
Stool Bacterial Pathogens Panel
Company
GREAT BASIN SCIENTIFIC, INC.
Model
GBSBPP-10
Catalog number
GBSBPP-10
Device description
Stool Bacterial Pathogens Panel Cartridge with sample prep device.
Published
2017-07-24
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
OOIReal Time Nucleic Acid Amplification System
PCHGastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
PCIGastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2
PCHGastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay SystemMicrobiology2
PCIGastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay SystemMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B178SBPP102PackageHIBCC10In Commercial Distribution
B178GBSBPP100PrimaryHIBCC0

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
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

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
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
B178GBSTEC102Shiga Toxin Direct TestGBSTEC-10GBSTEC-102016-09-23

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