FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Hepatitis Viral B Dna Detection
PMA: P050028
·
Supplement: S086
·
Decision Nov 14, 2022
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Hepatitis Viral B Dna Detection
- Trade Name
- COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test, v2.0
- PMA Number
- P050028
- Supplement Number
- S086
- 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
- November 14, 2022
- Date Received
- October 21, 2022
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Removal of an in-process testing (IPT) from the manufacturing process.
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 |