PMA P970055S023
- Device
- Parvovirus B19 IgM Enzyme Immunoassay
- Applicant
- Diasorin
- PMA number
- P970055
- Supplement
- S023
- Product code
- MYM
- Decision date
- 2024-07-12
- Classification
- Microbiology
- Generic name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM
- Approval order statement
- to change the cleaning process for equipment used to manufacture critical assay components
Current openFDA PMA Record#
- Device
- Parvovirus B19 IgM Enzyme Immunoassay
- Applicant
- Diasorin
- PMA number
- P970055
- Supplement
- S023
- Product code
- MYM
- Generic name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM
- Decision date
- 2024-07-12
- Decision code
- OK30
- Date received
- 2024-06-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to change the cleaning process for equipment used to manufacture critical assay components