PMA P970054S006
- Device
- PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY
- Applicant
- Diasorin
- PMA number
- P970054
- Supplement
- S006
- Product code
- MYL
- Decision date
- 2007-08-24
- Classification
- Assay,enzyme Linked Immunosorbent,parvovirus B19 Igg
- Generic name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG
- Approval order statement
- CHANGE IN PACKAGING MATERIAL.
Current openFDA PMA Record#
- Device
- PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY
- Applicant
- Diasorin
- PMA number
- P970054
- Supplement
- S006
- Product code
- MYL
- Generic name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG
- Decision date
- 2007-08-24
- Decision code
- OK30
- Date received
- 2007-07-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN PACKAGING MATERIAL.