PMA P970055S015
- Device
- Parvovirus B19 IgM Enzyme Immunoassay
- Applicant
- Diasorin
- PMA number
- P970055
- Supplement
- S015
- Product code
- MYM
- Decision date
- 2017-03-09
- Classification
- Assay,enzyme Linked Immunosorbent,parvovirus B19 Igm
- Generic name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM
- Approval order statement
- Addition of a variation test for materials used in the manufacture of kit reagents.
Current openFDA PMA Record#
- Device
- Parvovirus B19 IgM Enzyme Immunoassay
- Applicant
- Diasorin
- PMA number
- P970055
- Supplement
- S015
- Product code
- MYM
- Generic name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM
- Decision date
- 2017-03-09
- Decision code
- OK30
- Date received
- 2017-02-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a variation test for materials used in the manufacture of kit reagents.