FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Hepatitis Viral B Dna Detection
PMA: P200013
·
Supplement: S024
·
Decision Apr 11, 2025
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
- S024
- 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
- April 11, 2025
- Date Received
- March 14, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
a new vendor test method, test site, and test sensitivity used for the assay 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 |