9 results
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63ms
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Sources: EU EUDAMED, US FDA
Bordetella Direct Test
FDA UDI
GREAT BASIN SCIENTIFIC, INC.·B178GBBORD100·Bordetella Direct Test Cartridge
Stool Bacterial Pathogens Panel
FDA UDI
GREAT BASIN SCIENTIFIC, INC.·B178GBSBPP100·Stool Bacterial Pathogens Panel Cartridge with ...
Group B Strep Assay
FDA UDI
GREAT BASIN SCIENTIFIC, INC.·B178GBGBS100·
Shiga Toxin Direct Test
FDA UDI
GREAT BASIN SCIENTIFIC, INC.·B178GBSTEC100·Shiga Toxin Direct Test Cartridge with sample p...
Staph ID/R Blood Culture Panel
FDA UDI
GREAT BASIN SCIENTIFIC, INC.·B178GBSIDR100·
PA500 Portrait Analyzer
FDA UDI
GREAT BASIN SCIENTIFIC, INC.·B178PA5000·
Portrait Toxigenic C. difficile Assay
FDA UDI
GREAT BASIN SCIENTIFIC, INC.·B178GBCDIFF100·C. diff Assay Cartridge and Sample Prep Device.
Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R Blood Culture Panel is a qualitative, multiplex in vitro diagnostic assay intended for use with the P4500 PortraitrM Analyzer System. The Staph lD/R Blood Culture Panel is capable of simultaneous detection and identification ol Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensrs and various Staphylococcus species to the genus level and the detection of the mecA gene for methicillin resistance from patient positive blood culture specimens.
FDA Recall
Terminated
·Great Basin Scientific, Inc.·Product code PAM·December 12, 2016
Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R Blood Culture Panel is a qualitative, multiplex in vitro diagnostic assay intended for use with the P4500 PortraitrM Analyzer System. The Staph lD/R Blood Culture Panel is capable of simultaneous detection and identification ol Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensrs and various Staphylococcus species to the genus level and the detection of the mecA gene for methicillin resistance from patient positive blood culture specimens.
FDA Enforcement
Class II
·Terminated·Great Basin Scientific, Inc.·January 25, 2017