FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Hepatitis Viral B Dna Detection
PMA: P150014
·
Supplement: S006
·
Decision Dec 19, 2016
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Hepatitis Viral B Dna Detection
- Trade Name
- COBAS HBV
- PMA Number
- P150014
- Supplement Number
- S006
- 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
- December 19, 2016
- Date Received
- November 22, 2016
- Supplement Type
- Special (Immediate Track)
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Approval for the addition of the text and then briefly mix (e.g. vortex for 3-5 seconds) and other minor revisions to the IFU labeling.
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 |