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Sign in to claim this brandGreat Basin Scientific, Inc.
US
Last updated May 30, 2026
Information
- Country
- US
- Address
- —
- Website
- gbscience.com
- —
- —
- [email protected]
- Phone
- (888) 333-9763
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 827115259
Catalogue (10)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Staph ID/R Blood Culture Panel | GBSIDR-10 | FDA UDI | Class II | Active |
| Group B Strep Assay | GBGBS-10 | FDA UDI | Class II | Active |
| Bordetella Direct Test | GBBORD-10 | FDA UDI | Class II | Active |
| PA500 Portrait Analyzer | PA500 | FDA UDI | Class II | Active |
| Shiga Toxin Direct Test | GBSTEC-10 | FDA UDI | Class II | Active |
| Stool Bacterial Pathogens Panel | GBSBPP-10 | FDA UDI | Class II | Active |
| Portrait Toxigenic C. difficile Assay | GBCDIFF-10 | FDA UDI | Class II | Active |
| Great Basin Staph ID/R Blood Culture Panel | K152470 | FDA 510(k) | Class II | Active |
| Portrait Analyzer | DEN120013 | FDA 510(k) | Class I | Active |
| Great Basin Shiga Toxin Direct Test | K152955 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Dec 12, 2016 | Z-1051-2017 | — | terminated | The Great Basin Staph ID/R Panel is being recalled because the S. aureus probe could potentially result in a false positive. |