PMA P130015S007
- Device
- ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG
- Applicant
- Roche Diagnostics Operations, Inc.
- PMA number
- P130015
- Supplement
- S007
- Product code
- LOM
- Decision date
- 2016-10-24
- 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 the Elecsys® HBeAg Immunoassay and Elecsys® PreciControl HBeAg to the cobas e 602 immunoassay analyzer.
Current openFDA PMA Record#
- Device
- ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG
- Applicant
- Roche Diagnostics Operations, Inc.
- PMA number
- P130015
- Supplement
- S007
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2016-10-24
- Decision code
- APPR
- Date received
- 2016-04-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the migration of the Elecsys® HBeAg Immunoassay and Elecsys® PreciControl HBeAg to the cobas e 602 immunoassay analyzer.