This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the vitros immunodiagnostic products anti-hbs reagent pack and calibrators. The device is indicated for: the qualitative in vitro determination of total antibody to hepatitis b surface antigen (anti-hbs) in human serum using the vitros eci immunodiagnostic system. Assay results may be used as an aid in the determinatino 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.
| Device | VITROS IMMUNODIAGNOSTIC PRODUCTS:ANTI-HBS REAGENT PACK/ANTI-HBS CALIBRATORS |
| 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 | Ortho-Clinical Diagnostics, Inc. |
| Date Received | 2000-03-02 |
| Decision Date | 2000-09-29 |
| Notice Date | 2000-12-12 |
| PMA | P000014 |
| Supplement | S |
| Product Code | LOM |
| Docket Number | 00M-1658 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Dr. rochester, NY 14626-5101 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P000014 | Original Filing | |
| S036 | 2020-09-22 | 30-day Notice |
| S035 | 2019-05-21 | 30-day Notice |
| S034 | 2018-10-16 | Normal 180 Day Track No User Fee |
| S033 | 2018-02-21 | Normal 180 Day Track No User Fee |
| S032 | 2018-01-09 | Normal 180 Day Track No User Fee |
| S031 | 2015-08-10 | 30-day Notice |
| S030 | 2015-06-25 | 30-day Notice |
| S029 | 2015-06-24 | Normal 180 Day Track |
| S028 | 2014-11-14 | 30-day Notice |
| S027 | 2014-02-14 | 30-day Notice |
| S026 | 2012-10-17 | 30-day Notice |
| S025 | 2012-02-15 | 30-day Notice |
| S024 | 2011-10-05 | Real-time Process |
| S023 | 2011-02-14 | 30-day Notice |
| S022 | 2010-10-18 | 30-day Notice |
| S021 | 2010-07-27 | 30-day Notice |
| S020 | 2009-12-01 | Normal 180 Day Track No User Fee |
| S019 | 2009-09-04 | Normal 180 Day Track |
| S018 | 2009-03-06 | 30-day Notice |
| S017 | 2008-11-13 | Normal 180 Day Track No User Fee |
| S016 | 2008-01-23 | 30-day Notice |
| S015 | 2007-05-11 | 30-day Notice |
| S014 | 2006-05-12 | 30-day Notice |
| S013 | 2005-11-21 | 30-day Notice |
| S012 | 2005-05-09 | 30-day Notice |
| S011 | 2005-03-01 | 30-day Notice |
| S010 | 2004-10-26 | 30-day Notice |
| S009 | 2004-09-15 | Real-time Process |
| S008 | 2004-07-07 | 30-day Notice |
| S007 | 2004-05-05 | 30-day Notice |
| S006 | 2003-06-16 | 30-day Notice |
| S005 | 2003-01-30 | 30-day Notice |
| S004 | 2001-03-26 | Normal 180 Day Track |
| S003 | 2001-03-22 | 30-day Notice |
| S002 | 2001-03-12 | 135 Review Track For 30-day Notice |
| S001 | 2001-03-05 | 30-day Notice |