Great Basin Scientific, Inc.
Salt Lake City, UT, US
Great Basin Scientific, Inc. appears in FDA device records in Salt Lake City, UT. FDA records list 5 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Great Basin Scientific, Inc. between 2012 and 2017. The busiest year on record is 2016, with 2. The most recent is 2017, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2016 | 2 |
| 2017 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K163571 | Great Basin Stool Bacterial Pathogens Panel | PCI | Substantially Equivalent | |
| K170284 | Great Basin Bordetella Direct Test | OZZ | Substantially Equivalent | |
| K152470 | Great Basin Staph ID/R Blood Culture Panel | PAM | Substantially Equivalent | |
| K152955 | Great Basin Shiga Toxin Direct Test | PCH | Substantially Equivalent | |
| DEN120013 | PORTRAIT ANALYZER | OMN | Unknown |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- OZZBordetella Pertussis Dna Assay System
- OMNC. Difficile Nucleic Acid Amplification Test Assay
- PCIGastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System
- PCHGastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
- PAMGram-Positive Bacteria And Their Resistance Markers
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1051-2017 | 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. | The Great Basin Staph ID/R Panel is being recalled because the S. aureus probe could potentially result in a false positive. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain