FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Kit, Dna Detection, Human Papillomavirus
PMA: P890064
·
Decision Mar 11, 1991
Classifications
1
FEI Numbers
12
Registration Numbers
12
Basic Information
- Device Name
- Kit, Dna Detection, Human Papillomavirus
- Trade Name
- VIRATYPE HUMAN PAPILLOMAVIRUS DNA TYPING KIT
- PMA Number
- P890064
- Device Class
- FDA Class 3
- Product Code
- MAQ
- Generic Name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Medical Specialty
- Unknown
- Advisory Committee
- Microbiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 11, 1991
- Date Received
- November 17, 1989
- Expedited Review
- N
- Docket Number
- 91M-0108
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MAQ | Kit, Dna Detection, Human Papillomavirus | FDA class 3 | Unknown |