FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Hepatitis Viral B Dna Detection
PMA: P200013
·
Supplement: S022
·
Decision Sep 5, 2024
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Hepatitis Viral B Dna Detection
- Trade Name
- Alinity m HBV Assay
- PMA Number
- P200013
- Supplement Number
- S022
- 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 5, 2024
- Date Received
- August 8, 2024
- Supplement Type
- Special (Immediate Track)
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval to the request to include sample tube label requirements and edits to the the instrument Operations Manual Addendum.
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 |