Approval for the vitros immunodiagnostic products anti-hbc igm reagent pack and vitros immunodiagnostic products anti-hbc igm calibrator. These devices are indicated for: 1) vitros immunodiagnostic products anti-hbc igm reagent pack is indicated for the in vitro qualitative detection of igm antibody to hepatitis b core antigen (anti-hbc igm) in human adult and pediatric serum and plasma (heparin, edta and citrate) and neonate serum using the vitros eci immunodiagnostic system. Assay results, in conjunction with other serological and clinical information, may be used for the laboratory diagnosis of individuals with acute or chronic hepatitis b. 2) vitros immunodiagnostic products anti-hbc igm calibrator is indicated for the use in the calibration of the vitros immunodiagnostic system for the in vitro qualitative detection of igm antibody to hepatitis b core antigen (anti-hbc igm) in human adult and pediatric serum and plasma (edta, heparin or citrate) and neonate serum using vitro anti-hbc igm reagent packs.
| Device | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATOR |
| 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 | 2003-06-27 |
| Decision Date | 2004-03-04 |
| Notice Date | 2004-08-09 |
| PMA | P030026 |
| Supplement | S |
| Product Code | LOM |
| Docket Number | 04M-0356 |
| 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 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P030026 | | Original Filing |
| S037 |
2022-09-30 |
Real-time Process |
| S036 |
2019-05-21 |
30-day Notice |
| S035 |
2018-10-16 |
Normal 180 Day Track No User Fee |
| S034 |
2018-02-21 |
Normal 180 Day Track No User Fee |
| S033 |
2018-01-16 |
30-day Notice |
| S032 |
2018-01-09 |
Normal 180 Day Track No User Fee |
| S031 |
2015-10-05 |
30-day Notice |
| S030 |
2015-08-10 |
30-day Notice |
| S029 |
2015-01-16 |
30-day Notice |
| S028 |
2013-09-20 |
30-day Notice |
| S027 |
2012-11-29 |
30-day Notice |
| S026 |
2012-10-17 |
30-day Notice |
| S025 |
2012-01-30 |
30-day Notice |
| S024 |
2011-10-05 |
Real-time Process |
| S023 |
2011-05-19 |
30-day Notice |
| S022 |
2011-05-16 |
135 Review Track For 30-day Notice |
| S021 |
2010-12-08 |
30-day Notice |
| S020 |
2010-10-18 |
30-day Notice |
| S019 |
2009-12-01 |
Normal 180 Day Track No User Fee |
| S018 |
2009-05-22 |
30-day Notice |
| S017 |
2009-03-06 |
30-day Notice |
| S016 |
2009-02-20 |
Normal 180 Day Track |
| S015 |
2008-11-13 |
Normal 180 Day Track No User Fee |
| S014 |
2008-02-27 |
30-day Notice |
| S013 |
2007-03-08 |
30-day Notice |
| S012 |
2007-02-07 |
Special (immediate Track) |
| S011 |
2006-08-21 |
30-day Notice |
| S010 |
2006-05-17 |
30-day Notice |
| S009 |
2005-11-14 |
30-day Notice |
| S008 |
2005-09-30 |
Special (immediate Track) |
| S007 |
2005-06-27 |
30-day Notice |
| S006 |
2005-06-03 |
30-day Notice |
| S005 |
2005-04-07 |
30-day Notice |
| S004 |
2004-12-21 |
30-day Notice |
| S003 |
2004-12-15 |
30-day Notice |
| S002 |
2004-10-26 |
30-day Notice |
| S001 |
2004-05-24 |
30-day Notice |
NIH GUDID Devices