ADVIA Centaur HBsAg ReadyPack Reagents/ADVIA Centaur HBsAg Confirmatory ReadyPack Reagents, ADVIA Centaur HBsAg Quality

FDA Premarket Approval P030049 S016

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

This supplement is for labeling changes as a result of biotin interference testing.

DeviceADVIA Centaur HBsAg ReadyPack Reagents/ADVIA Centaur HBsAg Confirmatory ReadyPack Reagents, ADVIA Centaur HBsAg Quality
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
Date Received2020-12-22
Decision Date2021-03-11
PMAP030049
SupplementS016
Product CodeLOM 
Advisory CommitteeMicrobiology
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address SIEMENS HEALTHCARE DIAGNOSTICS 333 Coney Street walpole, MA 02032-1516

Supplemental Filings

Supplement NumberDateSupplement Type
P030049Original Filing
S016 2020-12-22 Real-time Process
S015 2020-07-31 30-day Notice
S014 2020-02-21 30-day Notice
S013 2019-09-27 30-day Notice
S012 2015-06-11 30-day Notice
S011 2014-07-10 Real-time Process
S010 2012-03-26 Normal 180 Day Track No User Fee
S009
S008 2010-04-06 30-day Notice
S007 2009-05-18 Normal 180 Day Track
S006 2009-05-12 30-day Notice
S005 2009-03-31 Normal 180 Day Track
S004 2009-03-09 Normal 180 Day Track No User Fee
S003 2009-02-04 30-day Notice
S002 2008-07-30 Normal 180 Day Track
S001

NIH GUDID Devices

Device IDPMASupp
00630414472881 P030049 000
00630414472874 P030049 002
00630414472867 P030049 002

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.