PMA P990044S022
- Device
- ETI-CORE-IGMK PLUS Assay
- Applicant
- DiaSorin, Inc.
- PMA number
- P990044
- Supplement
- S022
- Decision date
- 2018-03-14
- Approval order statement
- Add a filtration step and an in-process bioburden control to a raw material process, and to relocate a QC-testing process within the site.
Current openFDA PMA Record#
- Device
- ETI-CORE-IGMK PLUS Assay
- Applicant
- DiaSorin, Inc.
- PMA number
- P990044
- Supplement
- S022
- Decision date
- 2018-03-14
- Decision code
- OK30
- Date received
- 2018-02-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a filtration step and an in-process bioburden control to a raw material process, and to relocate a QC-testing process within the site.