Atellica IM Anti-Hepatitis B core Total (HBcT), Atellica IM Anti-Hepatitis B core Total Quality Control (HBcT QC)

Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)

FDA Premarket Approval P040004 S013

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

Approval for migration of the advia centaur hbc total assay (hbct) and the advia centaur hbc total (hbct) quality control onto the atellica im analyzer.

DeviceAtellica IM Anti-Hepatitis B core Total (HBcT), Atellica IM Anti-Hepatitis B core Total Quality Control (HBcT QC)
Classification NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
Date Received2017-07-17
Decision Date2018-07-06
PMAP040004
SupplementS013
Product CodeLOM
Advisory CommitteeMicrobiology
Supplement TypeNormal 180 Day Track
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
P040004Original Filing
S021 2022-03-22 30-day Notice
S020 2021-04-01 30-day Notice
S019 2020-12-22 Real-time Process
S018 2020-07-31 30-day Notice
S017 2020-03-09 30-day Notice
S016 2020-02-21 30-day Notice
S015 2019-02-01 30-day Notice
S014 2018-07-19 Real-time Process
S013 2017-07-17 Normal 180 Day Track
S012 2015-07-13 Normal 180 Day Track
S011 2015-06-11 30-day Notice
S010 2014-09-09 Normal 180 Day Track
S009 2012-03-26 Normal 180 Day Track No User Fee
S008 2012-01-09 30-day Notice
S007 2010-01-08 30-day Notice
S006 2009-05-18 Normal 180 Day Track
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 2008-08-26 Normal 180 Day Track
S001

NIH GUDID Devices

Device IDPMASupp
00630414498089 P040004 000
00630414599212 P040004 002
00630414599205 P040004 002
00630414498096 P040004 002
00630414301303 P040004 002

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