PMA P990042S021
- Device
- ETI-AB-AUK PLUS Assay
- Applicant
- DiaSorin, Inc.
- PMA number
- P990042
- Supplement
- S021
- Product code
- LOM
- Decision date
- 2018-03-14
- Classification
- Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- 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-AB-AUK PLUS Assay
- Applicant
- DiaSorin, Inc.
- PMA number
- P990042
- Supplement
- S021
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- 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.