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

DeviceElecsys Anti-HBs II
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantRoche Diagnostics
Date Received2021-11-29
Decision Date2021-12-16
PMAP190034
SupplementS001
Product CodeLOM 
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Roche Diagnostics 9115 Hague Road po Box 50416 indianapolis, IN 46250

Supplemental Filings

Supplement NumberDateSupplement Type
P190034Original Filing
S001 2021-11-29 30-day Notice

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