PMA P160019S003
- Device
- Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II
- Applicant
- Roche Diagnostics, Inc.
- PMA number
- P160019
- Supplement
- S003
- Product code
- LOM
- Decision date
- 2018-01-18
- 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 migration of the Elecsys HBsAg II, Elecsys HBsAg Confirmatory Test, and PreciControl HBsAg II onto the cobas e 411 immunoassay analyzer.
Current openFDA PMA Record#
- Device
- Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II
- Applicant
- Roche Diagnostics, Inc.
- PMA number
- P160019
- Supplement
- S003
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2018-01-18
- Decision code
- APPR
- Date received
- 2017-07-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for migration of the Elecsys HBsAg II, Elecsys HBsAg Confirmatory Test, and PreciControl HBsAg II onto the cobas e 411 immunoassay analyzer.