Devices

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.
Manufacturer
Great Basin Scientific, Inc.
1 Event
- Recall of Device Recall Great Basin Staph lD/R Blood Culture Panel

Manufacturer

Great Basin Scientific, Inc.

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

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