Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Great Basin Scientific with 4 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Jul 12, 2017: Great Basin Stool Bacterial Pathogens Panel.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 12, 2017 | Great Basin Stool Bacterial Pathogens PanelK163571 · PCI | 510(k) clearances |
| Mar 31, 2017 | Great Basin Bordetella Direct TestK170284 · OZZ | 510(k) clearances |
| Dec 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 diagnosticClass II · The Great Basin Staph ID/R Panel is being recalled because the S. aureus probe could potentially result in a false posit | Device recalls |
| Mar 25, 2016 | Great Basin Staph ID/R Blood Culture PanelK152470 · PAM | 510(k) clearances |
| Mar 22, 2016 | Great Basin Shiga Toxin Direct TestK152955 · PCH | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
