Elecsys Anti-HBs

FDA Premarket Approval P010054 S041

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
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantROCHE DIAGNOSTICS CORP.
Date Received2021-11-29
Decision Date2021-12-16
PMAP010054
SupplementS041
Product CodeLOM 
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ROCHE DIAGNOSTICS CORP. 9115 Hague Rd. indianapolis, IN 46250

Supplemental Filings

Supplement NumberDateSupplement Type
P010054Original Filing
S042 2021-12-02 30-day Notice
S041 2021-11-29 30-day Notice
S040 2018-10-26 Normal 180 Day Track No User Fee
S039 2018-10-09 30-day Notice
S038 2018-09-04 Normal 180 Day Track
S037 2018-04-27 Real-time Process
S036 2018-04-17 Real-time Process
S035 2018-03-01 Real-time Process
S034 2018-02-01 Normal 180 Day Track No User Fee
S033
S032 2017-10-11 Real-time Process
S031 2017-08-03 30-day Notice
S030 2017-05-24 30-day Notice
S029 2016-10-26 30-day Notice
S028 2016-02-16 30-day Notice
S027 2016-01-27 30-day Notice
S026 2016-01-27 135 Review Track For 30-day Notice
S025 2015-10-07 30-day Notice
S024 2014-11-25 30-day Notice
S023 2014-04-04 Real-time Process
S022 2013-04-09 Real-time Process
S021 2012-11-30 30-day Notice
S020
S019 2012-02-29 30-day Notice
S018 2012-01-31 135 Review Track For 30-day Notice
S017 2011-10-11 Normal 180 Day Track
S016 2011-08-29 135 Review Track For 30-day Notice
S015 2011-07-12 30-day Notice
S014 2011-05-17 Normal 180 Day Track No User Fee
S013 2011-04-11 30-day Notice
S012 2010-05-27 30-day Notice
S011 2009-12-22 Real-time Process
S010 2008-09-02 30-day Notice
S009 2008-06-09 Real-time Process
S008 2008-04-30 Normal 180 Day Track
S007 2007-09-04 Normal 180 Day Track
S006
S005 2006-07-11 Special (immediate Track)
S004 2006-06-13 Real-time Process
S003 2005-10-28 Real-time Process
S002 2005-09-15 Special (immediate Track)
S001 2004-12-22 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
04015630910908 P010054 000
04015630919420 P010054 000
04015630999286 P010054 001
07613336159781 P010054 034
07613336154014 P010054 038
07613336159804 P010054 038
07613336159798 P010054 038

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