Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) Assay

FDA Premarket Approval P100039 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

For moving manufacturing of atellica im analyzer’s component/subassembly named autoloader to an internal supplier

DeviceAtellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) Assay
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
Date Received2021-04-01
Decision Date2021-04-27
Product CodeLOM 
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address SIEMENS HEALTHCARE DIAGNOSTICS INC. 511 Benedict Ave. tarrytown, NY 10591

Supplemental Filings

Supplement NumberDateSupplement Type
P100039Original Filing
S013 2021-04-01 30-day Notice
S012 2021-03-26 30-day Notice
S011 2020-12-22 Real-time Process
S010 2020-07-31 30-day Notice
S009 2020-03-09 30-day Notice
S008 2020-02-21 30-day Notice
S007 2019-02-01 30-day Notice
S006 2018-07-19 Real-time Process
S005 2017-07-14 Normal 180 Day Track
S004 2015-07-13 Normal 180 Day Track
S003 2015-06-11 30-day Notice
S002 2012-09-28 Real-time Process
S001 2012-04-30 Normal 180 Day Track


Device IDPMASupp
00630414597843 P100039 001
00630414597836 P100039 001
00630414591407 P100039 001
00630414561790 P100039 001
00630414551777 P100039 001
00630414301273 P100039 001
00630414600512 P100039 002
00630414555300 P100039 002

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