PMA P990038S021
- Device
- ETI-MAK-2 PLUS ASSAY AND HBsAg CONFIRMATORY TEST ASSAYS
- Applicant
- DiaSorin, Inc.
- PMA number
- P990038
- Supplement
- S021
- Product code
- LOM
- Decision date
- 2016-06-08
- 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
- Removal of an in-process washing step for a raw material and replacement with additional supplier and manufacturing controls.
Current openFDA PMA Record#
- Device
- ETI-MAK-2 PLUS ASSAY AND HBsAg CONFIRMATORY TEST ASSAYS
- Applicant
- DiaSorin, Inc.
- PMA number
- P990038
- Supplement
- S021
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2016-06-08
- Decision code
- OK30
- Date received
- 2016-05-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removal of an in-process washing step for a raw material and replacement with additional supplier and manufacturing controls.