PMA P130015S003
- Device
- ELECSYS HBEAG IMMUNOASSAY/ELECSYS PRECICONTROL HBEAG
- Applicant
- Roche Diagnostics Operations, Inc.
- PMA number
- P130015
- Supplement
- S003
- Product code
- LOM
- Decision date
- 2015-07-28
- 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
- ADDITION OF A WEAK POSITIVE CONTROL TO THE IN-PROCESS TESTING OF THE DEVICE.
Current openFDA PMA Record#
- Device
- ELECSYS HBEAG IMMUNOASSAY/ELECSYS PRECICONTROL HBEAG
- Applicant
- Roche Diagnostics Operations, Inc.
- PMA number
- P130015
- Supplement
- S003
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2015-07-28
- Decision code
- OK30
- Date received
- 2015-06-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A WEAK POSITIVE CONTROL TO THE IN-PROCESS TESTING OF THE DEVICE.