Approval for the immulite anti-hbc igm and immulite 2000 anti-hbc igm. These devices are indicated for: immulite. Anti-hbc igm: immulite anti-hbc igm is a solid-phase chemiluminescent enzyme immunoassay designed for use with the immulite automated immunoassay analyzer for the qualitative measurement of igm antibody to hepatitis b core antigen (anti-hbc igm) in human serum and plasma (edta, heparinized or citrate). It is intended for in vitro diagnostic use for the laboratory diagnosis of acute or recent (usually within 6 months) hepatitis b viral infection. Immulite. 2000 anti-hbc igm: immulite 2000 anti-hbc igm is a solid-phase chemiluminescent enzyme immunoassay designed for use with the immulite 2000 automated immunoassay analyzer for the qualitative measurement if igm antibody to hepatitis b core antigen (anti-hbc igm) in human serum and plasma (edta, heparinized or citrate). It is intended for in vitro diagnostic use for the laboratory diagnosis of acute or recent (usually within 6 months) hepatitis b viral infection.
| Device | IMMULITE 2000 XPI ANTI-HBC IMG |
| 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 | P010053 |
| Supplement | S |
| Product Code | LOM |
| Docket Number | 03M-0272 |
| 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 |
|---|
| P010053 | | Original Filing |
| S016 |
2022-09-15 |
30-day Notice |
| S015 | | |
| S014 |
2022-02-28 |
30-day Notice |
| S013 |
2020-12-22 |
Real-time Process |
| S012 |
2020-08-12 |
30-day Notice |
| S011 |
2019-11-25 |
30-day Notice |
| S010 |
2011-12-19 |
135 Review Track For 30-day Notice |
| S009 |
2011-08-16 |
30-day Notice |
| S008 |
2011-08-08 |
30-day Notice |
| S007 |
2011-02-18 |
Real-time Process |
| S006 |
2009-11-02 |
Normal 180 Day Track No User Fee |
| S005 | | |
| S004 |
2008-11-10 |
Normal 180 Day Track No User Fee |
| S003 |
2005-08-17 |
Special (immediate Track) |
| S002 | | |
| S001 |
2002-11-20 |
Real-time Process |
NIH GUDID Devices