PMA P130015S013
- Device
- Elecsys HBeAg and PreciControl HBeAg
- Applicant
- Roche Diagnostics Operations, Inc.
- PMA number
- P130015
- Supplement
- S013
- Product code
- LOM
- Decision date
- 2018-03-02
- 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 HBeAg assay and PreciControl HBeAg on the MODULAR ANALYTICS E170 immunoassay analyzer to the cobas e 801 immunoassay analyzer.
Current openFDA PMA Record#
- Device
- Elecsys HBeAg and PreciControl HBeAg
- Applicant
- Roche Diagnostics Operations, Inc.
- PMA number
- P130015
- Supplement
- S013
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2018-03-02
- Decision code
- APPR
- Date received
- 2017-09-15
- 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 HBeAg assay and PreciControl HBeAg on the MODULAR ANALYTICS E170 immunoassay analyzer to the cobas e 801 immunoassay analyzer.