PMA P130015S005

Device: ELECSYS HBEAG IMMUNOASSAY
Applicant: Roche Diagnostics Operations, Inc.
PMA number: P130015
Supplement: S005
Product code: LOM
Decision date: 2016-08-08
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 changes to the final kit packaging configuration, modifications to an existing packaging line, and addition of two new packaging lines.

Current openFDA PMA Record#

Device: ELECSYS HBEAG IMMUNOASSAY
Applicant: Roche Diagnostics Operations, Inc.
PMA number: P130015
Supplement: S005
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2016-08-08
Decision code: APPR
Date received: 2016-01-27
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for changes to the final kit packaging configuration, modifications to an existing packaging line, and addition of two new packaging lines.