PMA P970054
- Device
- Parvovirus B 19 IgG Enzyme Immunoassay
- Applicant
- Diasorin
- PMA number
- P970054
- Supplement
- S020
- Product code
- MYL
- Decision date
- 2025-01-06
- Generic name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG
- Approval order statement
- a new piece of equipment required for manufacturing
Current openFDA PMA Record#
- Device
- Parvovirus B 19 IgG Enzyme Immunoassay
- Applicant
- Diasorin
- PMA number
- P970054
- Supplement
- S022
- Product code
- MYL
- Generic name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG
- Decision date
- 2025-01-06
- Decision code
- OK30
- Date received
- 2024-12-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a new piece of equipment required for manufacturing