Elecsys Anti-HBs II

FDA Premarket Approval P190034 S001

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

To improve and expand manufacturing of kit components

• Device: Elecsys Anti-HBs II
• Generic Name: Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
• Applicant: Roche Diagnostics
• Date Received: 2021-11-29
• Decision Date: 2021-12-16
• PMA: P190034
• Supplement: S001
• Product Code: LOM
• Advisory Committee: Microbiology
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: Roche Diagnostics 9115 Hague Road po Box 50416 indianapolis, IN 46250

Supplemental Filings

Supplement Number	Date	Supplement Type
P190034		Original Filing
S001	2021-11-29	30-day Notice

NIH GUDID Devices

Device ID	PMA	Supp
07613336160367	P190034	002
07613336230367	P190034	007