PMA P160019S012

Device: Elecsys HBsAg Confirmatory Test
Applicant: Roche Diagnostics, Inc.
PMA number: P160019
Supplement: S012
Product code: LOM
Decision date: 2021-12-09
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: Approval to change the serum source for the control and confirmatory reagents from human to sheep for the Elecsys HBsAg Confirmatory Test.

Current openFDA PMA Record#

Device: Elecsys HBsAg Confirmatory Test
Applicant: Roche Diagnostics, Inc.
PMA number: P160019
Supplement: S012
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2021-12-09
Decision code: APPR
Date received: 2021-08-02
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval to change the serum source for the control and confirmatory reagents from human to sheep for the Elecsys HBsAg Confirmatory Test.