Home GUDID B178SBPP102 Stool Bacterial Pathogens Panel
Primary DI B178SBPP102
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
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name PCI Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PCI Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B178SBPP102 Package HIBCC 10 In Commercial Distribution B178GBSBPP100 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Multiple 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 Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
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 DI Brand Model Catalog Published B178PA5000 PA500 Portrait Analyzer PA500 PA500 2016-09-23 B178GBSBPP100 Stool Bacterial Pathogens Panel GBSBPP-10 GBSBPP-10 2017-07-24 B178GBSTEC100 Shiga Toxin Direct Test GBSTEC-10 GBSTEC-10 2016-09-23 B178GBSIDR100 Staph ID/R Blood Culture Panel GBSIDR-10 GBSIDR-10 2016-09-23 B178GBSIDR102 Staph ID/R Blood Culture Panel GBSIDR-10 GBSIDR-10 2016-09-23 B178GBBORD100 Bordetella Direct Test GBBORD-10 GBBORD-10 2017-07-12 B178GBCDIFF100 Portrait Toxigenic C. difficile Assay GBCDIFF-10 GBCDIFF-10 2016-09-23 B178GBGBS100 Group B Strep Assay GBGBS-10 GBGBS-10 2016-09-23 B178GBSTEC102 Shiga Toxin Direct Test GBSTEC-10 GBSTEC-10 2016-09-23
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 30382904452798 Enteric Bacterial Panel Diluent for BD COR™ System BECTON, DICKINSON AND COMPANY PCI 2025-12-09 00382904448721 BD Enteric Bacterial Panel plus for BD COR™ System BECTON, DICKINSON AND COMPANY PCI 2025-12-09 00382904448738 BD Enteric Bacterial Panel for BD COR™ System BECTON, DICKINSON AND COMPANY PCI 2025-12-09 00840487101520 Enteric Pathogens (EP) Nucleic Acid Test Cartridge LUMINEX CORPORATION PCI 2019-12-05 00840487101544 Enteric Pathogens (EP) Amplification Tray LUMINEX CORPORATION PCI 2019-12-05 00840487101551 Enteric Pathogens (EP) Extraction Tray LUMINEX CORPORATION PCI 2019-12-05 00840487101568 Enteric Pathogens (EP) Stool Sample Preparation Kit LUMINEX CORPORATION PCI 2019-12-05 B178GBSBPP100 Stool Bacterial Pathogens Panel GREAT BASIN SCIENTIFIC, INC. PCI 2017-07-24 00382904429638 BD MAX™ Enteric Bacterial Panel BECTON, DICKINSON AND COMPANY PCI 2016-10-17 00857573006041 Enteric Pathogens (EP) Nucleic Acid Test Cartridge NANOSPHERE, INC. PCI 2016-09-23 00857573006058 Enteric Pathogens (EP) Extraction Tray NANOSPHERE, INC. PCI 2016-09-23 00857573006065 Enteric Pathogens (EP) Stool Sample Preparation Kit NANOSPHERE, INC. PCI 2016-09-23 00857573006089 Enteric Pathogens (EP) Amplification Tray NANOSPHERE, INC. PCI 2016-09-23 00382904433789 BD MAX™ Enteric Bacterial Panel (US/CAN) Geneohm Sciences Canada Inc PCI 2016-07-27
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