FDA.reportPublic FDA data

Bordetella Direct Test

Primary DI
B178GBBORD100
Brand
Bordetella Direct Test
Company
GREAT BASIN SCIENTIFIC, INC.
Model
GBBORD-10
Catalog number
GBBORD-10
Device description
Bordetella Direct Test Cartridge
Published
2017-07-12
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
OZZBordetella Pertussis Dna Assay System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2
OZZBordetella Pertussis Dna Assay SystemMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B178GBBORD102PackageHIBCC10In Commercial Distribution
B178GBBORD100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bordetella pertussis 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 Bordetella pertussis in a clinical specimen, using a nucleic acid technique (NAT). The assay is designed to detect infection with Bordetella pertussis, the bacteria associated with whooping cough.

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
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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