Approval for the immulite hbsag, immulite 2000 hbsag and immulite hbsag confirmatory kit. These devices are indicated for: immulite hbsag: immulite hbsag is a solid-phased chemiluminescent enzyme immunoassay designed for in vitro use with the immulite automated immunoassay analyzer for the qualitative detection of hepatitis b surface antigen (hbsag) in human serum or plasma (edta, heparinized, citrate). It is intended for in vitro diagnostic use for the laboratory diagnosis of acute and chronic hepatitis b virus infections in conjunction with other serological and clinical information. In addition, this assay may be used to screen for hepatitis b infection in pregnant women to identify neonates who are at high risk of acquiring hbv during the perinatal period. Immulite. 2000 hbsag: immulite 2000 hbsag is a solid-phase chemiluminescent enzyme immunoassay designed for in vitro use with the immulite 2000 automated immunoassay analyzer for the qualitative detection of hepatitis b surface antigen (hbsag) in human serum or plasma (edta, heparinized, citrate). It is intended for in vitro diagnostic use for the laboratory diagnosis of acute and chronic hepatitis b virus infections in conjunction with other serological and clinical information. In addition, this assay may be used to screen for hepatitis b infection in pregnant women to identify neonates who are at high risk of acquiring hbv during the perinatal period. Immulite hbsag confirmatory kit: immulite hbsag confirmatory is intended for in vitro diagnostic use in conjunction with the immulite hbsag or the immulite 2000 hbsag assays for the confirmation of the presence of hepatitis b surface antigen (hbsag) in human serum or plasma (edta, heparinized, citrate) that were repeatedly positive when tested by immulite or immulite 2000 hbsag.
| Device | IMMULITE 2000 XPI HBSAG |
| 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 | 2002-07-26 |
| Notice Date | 2003-06-24 |
| PMA | P010050 |
| Supplement | S |
| Product Code | LOM |
| Docket Number | 03M-0262 |
| 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 |
|---|
| 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