IMMULITE 2000/2000 XPi Anti-HBc IgM

FDA Premarket Approval P010053 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

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

DeviceIMMULITE 2000/2000 XPi Anti-HBc IgM
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantSiemens Healthcare Diagnostics Products, LTD
Date Received2020-12-22
Decision Date2021-03-11
PMAP010053
SupplementS013
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 Products, LTD glyn Rhonwy llanberis, Caernarfon LL55

Supplemental Filings

Supplement NumberDateSupplement Type
P010053Original Filing
S013 2020-12-22 Real-time Process
S012 2020-08-12 30-day Notice
S011 2019-11-25 30-day Notice
S010 2011-12-19 135 Review Track For 30-day Notice
S009 2011-08-16 30-day Notice
S008 2011-08-08 30-day Notice
S007 2011-02-18 Real-time Process
S006 2009-11-02 Normal 180 Day Track No User Fee
S005
S004 2008-11-10 Normal 180 Day Track No User Fee
S003 2005-08-17 Special (immediate Track)
S002
S001 2002-11-20 Real-time Process

NIH GUDID Devices

Device IDPMASupp
00630414977737 P010053 001
00630414977720 P010053 001
00630414960975 P010053 001

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