Company ยท US
Digene Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2001. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 25, 2001 | K010891 | MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01 Digene Corp. | LSK |
| Sep 24, 2001 | K010893 | MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01 Digene Corp. | LSL |
| Sep 24, 2001 | K010892 | MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01 Digene Corp. | LSK |
| Feb 29, 2000 | K981567 | HYBRID CAPTURE II CT/GC TEST Digene Corp. | LSL |
| Nov 29, 1999 | K981485 | HYBRID CAPTURE II GC-ID Digene Corp. | LSL |
| Oct 25, 1999 | K990023 | HYBRID CAPTURE II CT-ID TEST Digene Corp. | LSK |
| Sep 29, 1998 | K974901 | HYBRID CAPTURE SYSTEM CMV DNA ASSAY Digene Corp. | LJO |
| Feb 6, 1998 | K980120 | DIGENE DML 2000 MICROPLATE LUMINOMETER Digene Corp. | JJQ |
| Sep 19, 1997 | K971586 | DIGENE CERVICAL BRUSH Digene Corp. | HHT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Digene Corp Digene Hybrid Capture System CMV DNA Test (version 2.0), packaged in a cardboard box containing test reagents for performing 60 tests. Digene Catalog #4403-2003. Terminated |
LSO | None listed |
| Mar 19, 2003 | Digene Corp Hybrid Capture II CT-ID Test, Catalog #5135-1050IVT, (labeled for export only). Terminated |
MAQ | K990023 |
| Mar 19, 2003 | Digene Corp Hybrid Capture 2 High-Risk HPV DNA Test, Catalog # 5101-1296 Terminated |
MAQ | None listed |
| Mar 19, 2003 | Digene Corp Digene''s Hybrid Capture 2 HPV DNA Test, Catalog # 5196-1230, labeled for export only. Terminated |
MAQ | None listed |
| Mar 19, 2003 | Digene Corp Digene''s Hybrid Capture 2 HPV DNA Test, Catalog # 5101-1096 Terminated |
MAQ | None listed |