PMA supplement
P890064 S009: DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST
FDA PMA supplement · Panel Track · Qiagen Gaithersburg, Inc.
Key facts
| Original PMA | P890064 |
|---|---|
| Supplement number | S009 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST |
| Generic name | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
| Applicant | Qiagen Gaithersburg, Inc. |
| Product code | MAQ |
| Received date | Oct 1, 2001 |
| Decision date | Mar 31, 2003 |
| Docket number | 04M-0147 |
| Notice date | Apr 1, 2004 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: