FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Hepatitis Viral B Dna Detection
PMA: P080026
·
Supplement: S008
·
Decision Sep 10, 2013
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Hepatitis Viral B Dna Detection
- Trade Name
- ABBOTT REAL TIME HBV
- PMA Number
- P080026
- Supplement Number
- S008
- Device Class
- FDA Class 3
- Product Code
- MKT
- Generic Name
- Hepatitis Viral B DNA Detection
- Medical Specialty
- Unknown
- Advisory Committee
- Microbiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 10, 2013
- Date Received
- July 11, 2013
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A CHANGE TO A DATA REDUCTION PARAMETER IN THE APPLICATION SPECIFICATION FILES.
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 |
|---|---|---|---|
| MKT | Hepatitis Viral B Dna Detection | FDA class 3 | Unknown |