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 QiagenLabelled 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 Digene Corporation with 10 510(k) clearances. The most recent is a 510(k) clearance dated Sep 25, 2001: MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01.
| Sep 25, 2001 | MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01K010891 · LSK | 510(k) clearances |
| Sep 24, 2001 | MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01K010893 · LSL | 510(k) clearances |
| Sep 24, 2001 | MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01K010892 · LSK | 510(k) clearances |
| Feb 29, 2000 | HYBRID CAPTURE II CT/GC TESTK981567 · LSL | 510(k) clearances |
| Nov 29, 1999 | HYBRID CAPTURE II GC-IDK981485 · LSL | 510(k) clearances |
| Oct 25, 1999 | HYBRID CAPTURE II CT-ID TESTK990023 · LSK | 510(k) clearances |
| Sep 29, 1998 | HYBRID CAPTURE SYSTEM CMV DNA ASSAYK974901 · LJO | 510(k) clearances |
| Feb 6, 1998 | DIGENE DML 2000 MICROPLATE LUMINOMETERK980120 · JJQ | 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
