ADVIA Centaur aHBs2 Readypack Reagents and Quality Control Materials

FDA Premarket Approval P100039 S010

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

Procedure for testing raw materials, in-process and final products

DeviceADVIA Centaur aHBs2 Readypack Reagents and Quality Control Materials
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS INC.
Date Received2020-07-31
Decision Date2020-08-25
PMAP100039
SupplementS010
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
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

NIH GUDID Devices

Device IDPMASupp
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00630414555300 P100039 002

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