ANTI-HBS

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

FDA Premarket Approval P010052 S008

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 introduction of a new instrument model, the immulite 2000 xpi analyzer, as a new family member of the currently approved immulite 2000 analyzer, to be used with the currently approved immulite 2000 anti-hbs assay. The device, as modified, will be marketed under the trade immulite 2000 xpi anti-hbs assay and is indicated for in vitro diagnostic use for the detection of anti-hbs and is indicative of laboratory diagnosis of seroconversion from hepatitis b virus (hbv) infection.

DeviceANTI-HBS
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 Products, LTD
Date Received2011-02-18
Decision Date2011-05-12
PMAP010052
SupplementS008
Product CodeLOM
Advisory CommitteeMicrobiology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Siemens Healthcare Diagnostics Products, LTD glyn Rhonwy llanberis, Caernarfon LL55

Supplemental Filings

Supplement NumberDateSupplement Type
P010052Original Filing
S016 2022-09-15 30-day Notice
S015
S014 2020-08-12 30-day Notice
S013 2019-11-25 30-day Notice
S012 2014-11-28 135 Review Track For 30-day Notice
S011 2011-12-19 135 Review Track For 30-day Notice
S010 2011-08-16 30-day Notice
S009 2011-08-08 30-day Notice
S008 2011-02-18 Real-time Process
S007 2009-11-02 Normal 180 Day Track No User Fee
S006
S005 2008-11-10 Normal 180 Day Track No User Fee
S004 2008-02-25 Normal 180 Day Track
S003 2005-08-17 Special (immediate Track)
S002
S001 2002-11-20 Real-time Process

NIH GUDID Devices

Device IDPMASupp
00630414982182 P010052 001
00630414970998 P010052 001

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