PMA P100032S021

Device: Elecsys Anti-HBc II
Applicant: Roche Diagnostics Corp.
PMA number: P100032
Supplement: S021
Product code: LOM
Decision date: 2022-04-04
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: Approval for modification of the assay reagents to improve the tolerance to biotin interference, updating the sample stability claims, and revisions to the device labeling.

Current openFDA PMA Record#

Device: Elecsys Anti-HBc II
Applicant: Roche Diagnostics Corp.
PMA number: P100032
Supplement: S021
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2022-04-04
Decision code: APPR
Date received: 2021-09-30
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for modification of the assay reagents to improve the tolerance to biotin interference, updating the sample stability claims, and revisions to the device labeling.