PMA P990038S023
- Device
- ETI MAK-2 PLUS and HBsAg Confirmatory Test assays
- Applicant
- DiaSorin, Inc.
- PMA number
- P990038
- Supplement
- S023
- Product code
- LOM
- Decision date
- 2017-05-23
- 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
- Change to temperature and cycle parameters on instruments used to manufacture kit subcomponents.
Current openFDA PMA Record#
- Device
- ETI MAK-2 PLUS and HBsAg Confirmatory Test assays
- Applicant
- DiaSorin, Inc.
- PMA number
- P990038
- Supplement
- S023
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2017-05-23
- Decision code
- OK30
- Date received
- 2017-04-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to temperature and cycle parameters on instruments used to manufacture kit subcomponents.