Approval for the immulite anti-hbs and immulite 2000 anti-hbs. The devices are indicated for: immulite anti-hbs: for in vitro diagnostic use with the immulite automated immunoassay analyzer for the qualitative measurement of total antibodies to the hepatitis b surface antigen (anti-hbs) in human serum and plasma (heparinized or edta). Assay results may be used as an aid in the determination of susceptibility to hepatitis b virus (hbv) infection for individuals prior to or following hbv vaccination, or where vaccination status is unknown. Assay results may be used with other hbv serological markers for the laboratory diagnosis of hbv disease associated with hbv infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. The detection of anti-hbs is indicative of laboratory diagnosis of seroconversion from hepatitis b virus (hbv) infection. Immulite 2000 anti-hbs: for in vitro diagnostic use with the immulite 2000 automated immunoassay analyzer for the qualitative measurement of total antibodies to the hepatitis b surface antigen (anti-hbs) in human serum and plasma (heparinized or edta). Assay results may be used as an aid in the determination of susceptibility to hepatitis b virus (hbv) infection for individuals prior to or following hbv vaccination, or where vaccination status is unknown. Assay results may be used with other hbv serological markers for the laboratory diagnosis of hbv disease associated with hbv infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. The detection of anti-hbs is indicative of laboratory diagnosis of seroconversion from hepatitis b virus (hbv) infection.
| Device | IMMULITE 2000 XPI 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 | 2001-08-31 |
| Decision Date | 2002-07-22 |
| Notice Date | 2003-06-24 |
| PMA | P010052 |
| Supplement | S |
| Product Code | LOM |
| Docket Number | 03M-0287 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Siemens Healthcare Diagnostics Products, LTD glyn Rhonwy llanberis, Caernarfon LL55 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
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