PMA P970055S017
- Device
- Parvovirus B19 IgM Enzyme Immunoassay (V619IMUS)
- Applicant
- Diasorin
- PMA number
- P970055
- Supplement
- S017
- Product code
- MYM
- Decision date
- 2019-06-13
- Classification
- Assay,enzyme Linked Immunosorbent,parvovirus B19 Igm
- Generic name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM
- Approval order statement
- Approval for relocating the manufacturing site to DiaSorin S.p.A., at Via Crescentino Snc, Saluggia, Italy.
Current openFDA PMA Record#
- Device
- Parvovirus B19 IgM Enzyme Immunoassay (V619IMUS)
- Applicant
- Diasorin
- PMA number
- P970055
- Supplement
- S017
- Product code
- MYM
- Generic name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM
- Decision date
- 2019-06-13
- Decision code
- APPR
- Date received
- 2018-08-08
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for relocating the manufacturing site to DiaSorin S.p.A., at Via Crescentino Snc, Saluggia, Italy.