PMA P010054S037
- Device
- Elecsys Ani-HBs, PreciControl Anti-HBs and Anti-HBs CalCheck
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P010054
- Supplement
- S037
- Product code
- LOM
- Decision date
- 2018-07-13
- 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
- Approval for the addition of K2-EDTA plasma as a matrix.
Current openFDA PMA Record#
- Device
- Elecsys Ani-HBs, PreciControl Anti-HBs and Anti-HBs CalCheck
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P010054
- Supplement
- S037
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2018-07-13
- Decision code
- APPR
- Date received
- 2018-04-27
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the addition of K2-EDTA plasma as a matrix.