PMA P970055S020
- Device
- Parvovirus B19 IgM Enzyme Immunoassay
- Applicant
- Diasorin
- PMA number
- P970055
- Supplement
- S020
- Product code
- MYM
- Decision date
- 2020-04-21
- Generic name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM
- Approval order statement
- Replace a critical raw material (and its supplier) used in the shipment of manufactured kits.
Current openFDA PMA Record#
- Device
- Parvovirus B19 IgM Enzyme Immunoassay
- Applicant
- Diasorin
- PMA number
- P970055
- Supplement
- S020
- Product code
- MYM
- Generic name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM
- Decision date
- 2020-04-21
- Decision code
- OK30
- Date received
- 2020-03-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replace a critical raw material (and its supplier) used in the shipment of manufactured kits.