PMA P110031S017
- Device
- COBAS E 411
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P110031
- Supplement
- S017
- Product code
- LOM
- Decision date
- 2017-02-28
- 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 addition of K3-EDTA plasma as a specimen type for the Elecsys Anti-HBc IgM immunoassay for use on the cobas e 411, cobas e 601, cobas e 602, and MODULAR ANALYTICS E170 analyzers.
Current openFDA PMA Record#
- Device
- COBAS E 411
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P110031
- Supplement
- S017
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2017-02-28
- Decision code
- APPR
- Date received
- 2016-12-07
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the addition of K3-EDTA plasma as a specimen type for the Elecsys Anti-HBc IgM immunoassay for use on the cobas e 411, cobas e 601, cobas e 602, and MODULAR ANALYTICS E170 analyzers.