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.
Device | ANTI-HBS |
Classification Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
Applicant | Siemens Healthcare Diagnostics Products, LTD |
Date Received | 2011-02-18 |
Decision Date | 2011-05-12 |
PMA | P010052 |
Supplement | S008 |
Product Code | LOM |
Advisory Committee | Microbiology |
Supplement Type | Real-time Process |
Supplement Reason | Change Design/components/specifications/material |
Expedited Review | No |
Combination Product | No |
Applicant Address | Siemens Healthcare Diagnostics Products, LTD glyn Rhonwy llanberis, Caernarfon LL55 |
Supplemental Filings
Supplement Number | Date | Supplement Type |
P010052 | | Original 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