PMA P050049S007
- Device
- ABBOTT AXSYM HBSAG & HBSAG CONFIRMATORY
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050049
- Supplement
- S007
- Product code
- LOM
- Decision date
- 2011-07-01
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- ADDITION OF AN HBSAG POSITIVE PLASMA SUPPLIER AND A CHANGE TO QUALITY CONTROL TESTING.
Current openFDA PMA Record#
- Device
- ABBOTT AXSYM HBSAG & HBSAG CONFIRMATORY
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050049
- Supplement
- S007
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2011-07-01
- Decision code
- OK30
- Date received
- 2011-06-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF AN HBSAG POSITIVE PLASMA SUPPLIER AND A CHANGE TO QUALITY CONTROL TESTING.