PMA P190005S001
- Device
- Elecsys Anti-HBe, PreciControl Anti-HBe
- Applicant
- Roche Diagnostics
- PMA number
- P190005
- Supplement
- S001
- Product code
- LOM
- Decision date
- 2021-11-01
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- Approval for use of the Elecsys Anti-HBe with the cobas e 801 immunoassay analyzer.
Current openFDA PMA Record#
- Device
- Elecsys Anti-HBe, PreciControl Anti-HBe
- Applicant
- Roche Diagnostics
- PMA number
- P190005
- Supplement
- S001
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2021-11-01
- Decision code
- APPR
- Date received
- 2021-04-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for use of the Elecsys Anti-HBe with the cobas e 801 immunoassay analyzer.