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 HologicLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Gen-Probe Prodesse with 10 510(k) clearances. The most recent is a 510(k) clearance dated Aug 26, 2013: PRODESSE PROFAST+ ASSAY.
| Aug 26, 2013 | PRODESSE PROFAST+ ASSAYK132237 · OQW | 510(k) clearances |
| Aug 26, 2013 | PROPARAFLU+ ASSAYK132238 · OOU | 510(k) clearances |
| Aug 14, 2013 | PROADENO+ ASSAYK132159 · OCC | 510(k) clearances |
| Aug 14, 2013 | PRO HMPV+ ASSAYK132200 · OEM | 510(k) clearances |
| Aug 9, 2013 | PRODESSE PROFLU+ ASSAYK132129 · OCC | 510(k) clearances |
| Jan 16, 2013 | PRO HMPV+ ASSAYK123838 · OEM | 510(k) clearances |
| Jan 16, 2013 | PROGASTRO SSCS ASSAYK123274 · PCH | 510(k) clearances |
| Jun 27, 2011 | PROFLU+ ASSAYK110968 · OCC | 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
