K010892
Substantially EquivalentMODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01
- Applicant
- Digene Corp.
- Product code
- LSK
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gaithersburg, MD, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.