Approval for the vitros immunodiagnostic products anti-hbc reagent pack and vitros immunodiagnostic products anti-hbc calibrator. These devices are indicated for: 1) vitros immunodiagnostic products anti-hbc reagent pack is indicated for the in vitro qualitative detection of total antibody (igg and igm) to hepatitis b core antigen (total anti-hbc) in human adult and pediatric serum and plasma (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, or recovery from hepatitis b infection. The presence of anti-hbc may be used as an aid in the determination of exposure to hbv infection for individuals prior to hbv vaccination. 2) vitros immunodiagnostic products anti-hbc calibrator is indicated for use in the calibration of the vitros eci immunodiagnostic system when used for the in vitro qualitative detection of total antibody (igg and igm) to hepatitis b core antigen (total anti-hbc) in human adult and pediatric serum and plasma (edta and citrate) and neonate serum using vitros anti-hbc reagent packs.
| Device | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/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 |
| Date Received | 2003-06-19 |
| Decision Date | 2004-03-04 |
| Notice Date | 2004-08-04 |
| PMA | P030024 |
| Supplement | S |
| Product Code | LOM |
| Docket Number | 04M-0341 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ORTHO-CLINICAL DIAGNOSTICS 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 |
|---|
| P030024 | | Original Filing |
| S029 |
2019-05-21 |
30-day Notice |
| S028 |
2018-10-16 |
Normal 180 Day Track No User Fee |
| S027 |
2018-09-17 |
30-day Notice |
| S026 |
2018-02-21 |
Normal 180 Day Track No User Fee |
| S025 |
2018-01-09 |
Normal 180 Day Track No User Fee |
| S024 |
2017-08-07 |
30-day Notice |
| S023 |
2015-08-10 |
30-day Notice |
| S022 |
2015-06-25 |
30-day Notice |
| S021 |
2013-08-12 |
30-day Notice |
| S020 |
2012-10-17 |
30-day Notice |
| S019 |
2012-05-04 |
30-day Notice |
| S018 |
2012-01-30 |
30-day Notice |
| S017 |
2011-10-05 |
Real-time Process |
| S016 |
2011-05-16 |
135 Review Track For 30-day Notice |
| S015 |
2011-04-15 |
30-day Notice |
| S014 |
2010-12-06 |
135 Review Track For 30-day Notice |
| S013 |
2010-10-18 |
30-day Notice |
| S012 |
2009-12-01 |
Normal 180 Day Track No User Fee |
| S011 |
2009-03-06 |
30-day Notice |
| S010 |
2009-02-12 |
Normal 180 Day Track |
| S009 |
2008-11-13 |
Normal 180 Day Track No User Fee |
| S008 |
2008-01-23 |
30-day Notice |
| S007 |
2007-12-10 |
Real-time Process |
| S006 |
2007-05-11 |
30-day Notice |
| S005 |
2006-05-15 |
30-day Notice |
| S004 |
2005-11-14 |
30-day Notice |
| S003 |
2005-04-08 |
Special (immediate Track) |
| S002 |
2004-10-26 |
30-day Notice |
| S001 |
2004-03-17 |
30-day Notice |
NIH GUDID Devices