PMA P110022S013
- Device
- ELECSYS ANTI-HBC IGM ON COBAS E 601
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P110022
- Supplement
- S013
- Product code
- LOM
- Decision date
- 2014-11-26
- 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 SOFTWARE UPDATES OF THE US SPECIFIC E-BARCODE FOR THE COBAS E 601 AND THE US SPECIFIC ASSAY BARCODE TRANSFER SHEET FOR THE MODULAR ANALYTICS E170 TO IMPLEMENT THE GREY-ZONE.
Current openFDA PMA Record#
- Device
- ELECSYS ANTI-HBC IGM ON COBAS E 601
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P110022
- Supplement
- S013
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2014-11-26
- Decision code
- APPR
- Date received
- 2014-10-16
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR SOFTWARE UPDATES OF THE US SPECIFIC E-BARCODE FOR THE COBAS E 601 AND THE US SPECIFIC ASSAY BARCODE TRANSFER SHEET FOR THE MODULAR ANALYTICS E170 TO IMPLEMENT THE GREY-ZONE.