FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
PMA: P220034
·
Supplement: S003
·
Decision Jan 6, 2025
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
- Trade Name
- LIAISON Biotrin Parvovirus B19 lgG Plus and LIAISON Biotrin Control Parvovirus B19 IgG Plus
- PMA Number
- P220034
- Supplement Number
- S003
- Device Class
- FDA Class 3
- Product Code
- MYL
- Generic Name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG
- Medical Specialty
- Unknown
- Advisory Committee
- Microbiology
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- January 6, 2025
- Date Received
- December 10, 2024
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
a new piece of equipment required for manufacturing
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 |
|---|---|---|---|
| MYL | Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg | FDA class 3 | Unknown |