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., part of Thermo Fisher ScientificLabelled 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 14, 2026, FDA's public records list Mesa Biotech with 3 510(k) clearances and 1 device recall. The most recent is a device recall dated Apr 6, 2022: Accula SARS-CoV-2 Test, REF: COV4100.
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.
| Apr 6, 2022 | Accula SARS-CoV-2 Test, REF: COV4100Class I · SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis an | Device recalls |
| Nov 9, 2020 | Accula Strep A TestK201269 · PGX | 510(k) clearances |
| Nov 23, 2018 | Accula RSV TestK181443 · OCC | 510(k) clearances |
| Feb 6, 2018 | Accula Flu A/Flu B TestK171641 · OZE | 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
