Approval for an automated means of confirmation testing on-board the immulite 2000 immunoassay analyzer. The device, as modified, will be marketed under the trade name immulite 2000 hbsag confirmatory kit and is indicated for: immulite 2000 hbsag confirmatory is intended for in vitro diagnostic use with immulite 2000 analyzers in conjunction with the immulite 2000 hbsag assay - for the confirmation of the presence of hepatitis b surface antigen (hbsag) in human serum or plasma (edta, heparinized, citrate) that were repeatedly reactive when tested by the immulite/ immulite 1000 hbsag assay or by the immulite 2000 hbsag assay.
| Device | IMMULITE 2000 HBS AG CONFIRMATORY KIT |
| 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 | 2010-09-29 |
| Decision Date | 2011-06-24 |
| PMA | P010050 |
| Supplement | S011 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| 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 |
|---|
| P010050 | | Original Filing |
| S021 |
2022-09-15 |
30-day Notice |
| S020 | | |
| S019 |
2021-05-12 |
30-day Notice |
| S018 |
2020-08-12 |
30-day Notice |
| S017 |
2019-11-25 |
30-day Notice |
| S016 |
2014-07-02 |
135 Review Track For 30-day Notice |
| S015 |
2011-12-19 |
135 Review Track For 30-day Notice |
| S014 |
2011-08-16 |
30-day Notice |
| S013 |
2011-08-08 |
30-day Notice |
| S012 |
2011-02-18 |
Real-time Process |
| S011 |
2010-09-29 |
Normal 180 Day Track |
| S010 |
2009-11-02 |
Normal 180 Day Track No User Fee |
| S009 | | |
| S008 |
2009-05-13 |
Real-time Process |
| S007 |
2008-12-02 |
Normal 180 Day Track |
| S006 |
2008-11-10 |
Normal 180 Day Track No User Fee |
| S005 |
2006-08-04 |
30-day Notice |
| S004 | | |
| S003 |
2003-05-22 |
30-day Notice |
| S002 | | |
| S001 |
2002-11-20 |
Real-time Process |
NIH GUDID Devices