Approval for replacement of the sodium based buffer with potassium phosphatebuffer and addition of 2. 0% normal mouse serum and 1. 2% e-amino-n-caproic acid in reagent a,and the addition of 0. 2% sodium heparin in reagent b followed by refiltering of diluent, and isindicated for in vitro diagnostic use for the laboratory diagnosis of acute and chronic hepatitis bvirus infections in conjunction with other serological and clinical information.
| Device | IMMULITE & IMMULITE 2000 HBSAG ASSAY |
| 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 | 2008-12-02 |
| Decision Date | 2009-02-09 |
| PMA | P010050 |
| Supplement | S007 |
| 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