PMA P970055S005
- Device
- PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY
- Applicant
- Diasorin
- PMA number
- P970055
- Supplement
- S005
- Product code
- MYM
- Decision date
- 2007-10-10
- Classification
- Assay,enzyme Linked Immunosorbent,parvovirus B19 Igm
- Generic name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM
- Approval order statement
- APPROVAL FOR THE REDUCTION IN PLATE WASH VOLUME.
Current openFDA PMA Record#
- Device
- PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY
- Applicant
- Diasorin
- PMA number
- P970055
- Supplement
- S005
- Product code
- MYM
- Generic name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM
- Decision date
- 2007-10-10
- Decision code
- APPR
- Date received
- 2007-06-01
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE REDUCTION IN PLATE WASH VOLUME.