PMA P970055S012
- Device
- BIOTRIN PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY
- Applicant
- Diasorin
- PMA number
- P970055
- Supplement
- S012
- Product code
- MYM
- Decision date
- 2011-12-29
- Classification
- Assay,enzyme Linked Immunosorbent,parvovirus B19 Igm
- Generic name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM
- Approval order statement
- MANUFACTURING LOCATION AND QC TESTING SEQUENCE CHANGES FOR STREPTAVIDIN-HRP SUBSTRATE.
Current openFDA PMA Record#
- Device
- BIOTRIN PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY
- Applicant
- Diasorin
- PMA number
- P970055
- Supplement
- S012
- Product code
- MYM
- Generic name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM
- Decision date
- 2011-12-29
- Decision code
- OK30
- Date received
- 2011-12-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MANUFACTURING LOCATION AND QC TESTING SEQUENCE CHANGES FOR STREPTAVIDIN-HRP SUBSTRATE.