PMA P100039S007
- Device
- Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) Assay
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P100039
- Supplement
- S007
- Product code
- LOM
- Decision date
- 2019-03-08
- 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
- Adding an additional manufacturing site for the instrument module.
Current openFDA PMA Record#
- Device
- Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) Assay
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P100039
- Supplement
- S007
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2019-03-08
- Decision code
- OK30
- Date received
- 2019-02-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adding an additional manufacturing site for the instrument module.