PMA P970054S001
- Device
- BIOTRON PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY
- Applicant
- Diasorin
- PMA number
- P970054
- Supplement
- S001
- Product code
- MYL
- Decision date
- 2003-01-09
- Classification
- Assay,enzyme Linked Immunosorbent,parvovirus B19 Igg
- Generic name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG
- Approval order statement
- APPROVAL FOR ADDING A QUALITY ASSURANCE INSPECTION STEP.
Current openFDA PMA Record#
- Device
- BIOTRON PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY
- Applicant
- Diasorin
- PMA number
- P970054
- Supplement
- S001
- Product code
- MYL
- Generic name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG
- Decision date
- 2003-01-09
- Decision code
- APPR
- Date received
- 2002-11-15
- Supplement type
- Special (Immediate Track)
- Approval order statement
- APPROVAL FOR ADDING A QUALITY ASSURANCE INSPECTION STEP.