Approval for the vitros immunodiagnostic products hbeag reagent pack, calibrator and controls. This device is indicated for: vitros immunodiagnostic products hbeag reagent pack for the in vitro qualitative detection of hepatitis b e antigen (hbeag) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of hepatitis or who may be at risk for hepatitis b virus (hbv) infection using the vitros eci/eciq immunodiagnostic system. Test 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. Vitros immunodiagnostic products hbeag calibrator for use in the calibration of the vitros eci/eciq immunodiagnostic systems for the in vitro qualitative detection of hepatitis b e antigen (hbeag) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of hepatitis or who may be at risk for hepatitis b virus (hbv) infection. Vitros immunodiagnostic products hbeag controls - for use in monitoring the performance of the vitros eci/eciq immunodiagnostic systems when used for the in vitro qualitative detection of hepatitis b e antigen (hbeag) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of hepatitis or who may be at risk for hepatitis b virus (hbv) infection when using the vitros immunodiagnostic products hbe-ag reagent pack.
| Device | VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS |
| 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 | 2009-12-16 |
| Decision Date | 2011-05-11 |
| Notice Date | 2011-05-20 |
| PMA | P090028 |
| Supplement | S |
| Product Code | LOM |
| Docket Number | 11M-0348 |
| 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 |
|---|
| P090028 | | Original Filing |
| S018 |
2022-09-30 |
Real-time Process |
| S017 |
2019-05-21 |
30-day Notice |
| S016 |
2018-10-16 |
Normal 180 Day Track No User Fee |
| S015 |
2018-02-21 |
Normal 180 Day Track No User Fee |
| S014 |
2018-02-12 |
30-day Notice |
| S013 |
2018-01-09 |
Normal 180 Day Track No User Fee |
| S012 | | |
| S011 |
2017-09-25 |
30-day Notice |
| S010 |
2016-12-02 |
Normal 180 Day Track |
| S009 |
2015-08-10 |
30-day Notice |
| S008 |
2015-06-25 |
30-day Notice |
| S007 |
2013-09-20 |
30-day Notice |
| S006 |
2012-11-29 |
30-day Notice |
| S005 |
2012-11-15 |
30-day Notice |
| S004 |
2012-10-17 |
30-day Notice |
| S003 |
2012-09-19 |
30-day Notice |
| S002 |
2012-03-22 |
30-day Notice |
| S001 |
2011-10-11 |
30-day Notice |
NIH GUDID Devices