PMA P990038S032
- Device
- ETI-MAK-2 PLUS and HBsAg Confirmatory Test assay
- Applicant
- DiaSorin, Inc.
- PMA number
- P990038
- Supplement
- S032
- Product code
- LOM
- Decision date
- 2021-12-21
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- Subcontract manufacturing equipment cleaning processes.
Current openFDA PMA Record#
- Device
- ETI-MAK-2 PLUS and HBsAg Confirmatory Test assay
- Applicant
- DiaSorin, Inc.
- PMA number
- P990038
- Supplement
- S032
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2021-12-21
- Decision code
- OK30
- Date received
- 2021-11-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Subcontract manufacturing equipment cleaning processes.