International Medical Devices Database

Manufacturer Address
Great Basin Scientific, Inc., 2441 S 3850 W, Salt Lake City UT 84120-7209
Manufacturer Parent Company (2017)
Great Basin Scientific, Inc.
Source
USFDA
1 Event
- Recall of Device Recall Great Basin Staph lD/R Blood Culture Panel

One device in the database

Device Recall Great Basin Staph lD/R Blood Culture Panel

Model / Serial
Lot 1629103 Catalog Number: GBSIDR-10 Unique Device ldentifier (UDl): B1 78GBS|DR102
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
US Nationwide Distribution.
Product Description
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.

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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Great Basin Scientific, Inc.

One device in the database

Device Recall Great Basin Staph lD/R Blood Culture Panel