PMA P970054S009
- Device
- BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY
- Applicant
- Diasorin
- PMA number
- P970054
- Supplement
- S009
- Product code
- MYL
- Decision date
- 2012-09-05
- Classification
- Assay,enzyme Linked Immunosorbent,parvovirus B19 Igg
- Generic name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIOTRIN INTERNATIONAL LTD IN DUBLIN, IRELAND.
Current openFDA PMA Record#
- Device
- BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY
- Applicant
- Diasorin
- PMA number
- P970054
- Supplement
- S009
- Product code
- MYL
- Generic name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG
- Decision date
- 2012-09-05
- Decision code
- APPR
- Date received
- 2011-06-24
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIOTRIN INTERNATIONAL LTD IN DUBLIN, IRELAND.