FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Hepatitis Viral B Dna Detection
PMA: P080026
·
Supplement: S019
·
Decision Dec 13, 2016
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Hepatitis Viral B Dna Detection
- Trade Name
- ABBOTT REALTIME HBV ASSAY/ CALIBRATOR KIT/CONTROL KIT & ABBOTT MSAMPLE PREPARATION SYSTEM DNA
- PMA Number
- P080026
- Supplement Number
- S019
- Device Class
- FDA Class 3
- Product Code
- MKT
- Generic Name
- Hepatitis Viral B DNA Detection
- Medical Specialty
- Unknown
- Advisory Committee
- Microbiology
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- December 13, 2016
- Date Received
- November 16, 2016
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Addition of a purified water source to be used in the manufacture of bulk reagents, and the addition of a supplier for a raw material used for the manufacture of bulk reagents.
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 |