PMA P130015S001
- Device
- ELECSYS HBEAG IMMUNOASSAY AND ELECSYS PRECICONTROL HBEAG
- Applicant
- Roche Diagnostics Operations, Inc.
- PMA number
- P130015
- Supplement
- S001
- Product code
- LOM
- Decision date
- 2014-06-06
- 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
- CHANGES TO THE IN-PROCESS TEST PROCEDURE FOR THE BULK POSITIVE CONTROL AND TO THE MANUFACTURING PROCESS FOR FILLING OF THE STREPTAVIDIN COATED BEADS.
Current openFDA PMA Record#
- Device
- ELECSYS HBEAG IMMUNOASSAY AND ELECSYS PRECICONTROL HBEAG
- Applicant
- Roche Diagnostics Operations, Inc.
- PMA number
- P130015
- Supplement
- S001
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2014-06-06
- Decision code
- OK30
- Date received
- 2014-05-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE IN-PROCESS TEST PROCEDURE FOR THE BULK POSITIVE CONTROL AND TO THE MANUFACTURING PROCESS FOR FILLING OF THE STREPTAVIDIN COATED BEADS.