PMA P010054S038
- Device
- Elecsys Anti-HBs; PreciControl Anti-HBs; Anti-HBs CalCheck
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P010054
- Supplement
- S038
- Product code
- LOM
- Decision date
- 2019-04-15
- 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 migration of claims from the FDA approved Elecsys Anti-HBs, Anti-HBs CalCheck and PreciControl Anti-HBs on the cobas e 601 immunoassay analyzer to the cobas e 801 immunoassay analyzer.
Current openFDA PMA Record#
- Device
- Elecsys Anti-HBs; PreciControl Anti-HBs; Anti-HBs CalCheck
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P010054
- Supplement
- S038
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2019-04-15
- Decision code
- APPR
- Date received
- 2018-09-04
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the migration of claims from the FDA approved Elecsys Anti-HBs, Anti-HBs CalCheck and PreciControl Anti-HBs on the cobas e 601 immunoassay analyzer to the cobas e 801 immunoassay analyzer.