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.
The device is intended for the qualitative detection if igm antibodies to b19 virus (b19v, previously known as human parvovirus b19) in human seru, lithium heparin, edta, and citrated plasma. This test, in conjunction with the biotrin parvovirus b19 igg enzyme immunoassay, may be used for testing women of childbearing age to determine their serological status where there is a suspicion of exposure with b19v. The results of these assays may be used to make a serological determination of past, recent, or current infection with b19v. The clinician should consider the results of these assays as presumptive for risk of fetal infection with b19v. The test may also be used for all patients as an aid in the diagnosis of fifth disease (erythema infectiosum).
| Device | BIOTRIN PARVOVIRUS IGM EIA (V619IMUS) |
| Classification Name | Assay,enzyme Linked Immunosorbent,parvovirus B19 Igm |
| Generic Name | Assay,enzyme Linked Immunosorbent,parvovirus B19 Igm |
| Applicant | DIASORIN |
| Date Received | 1997-08-28 |
| Decision Date | 1999-08-06 |
| PMA | P970055 |
| Supplement | S |
| Product Code | MYM |
| Docket Number | 00M-1215 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DIASORIN 1951 Northwestern Avenue stillwater, MN 55082-0285 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P970055 | Original Filing | |
| S022 | 2021-11-23 | 30-day Notice |
| S021 | 2020-07-16 | 30-day Notice |
| S020 | 2020-03-30 | 30-day Notice |
| S019 | 2019-03-22 | 30-day Notice |
| S018 | ||
| S017 | 2018-08-08 | Normal 180 Day Track No User Fee |
| S016 | ||
| S015 | 2017-02-08 | 30-day Notice |
| S014 | 2016-12-22 | 30-day Notice |
| S013 | 2013-11-27 | 30-day Notice |
| S012 | 2011-12-06 | 30-day Notice |
| S011 | 2011-07-06 | 30-day Notice |
| S010 | 2011-06-24 | Normal 180 Day Track No User Fee |
| S009 | 2010-05-14 | 30-day Notice |
| S008 | 2010-02-17 | 30-day Notice |
| S007 | 2009-02-09 | 30-day Notice |
| S006 | 2007-07-31 | 30-day Notice |
| S005 | 2007-06-01 | 135 Review Track For 30-day Notice |
| S004 | 2007-05-14 | 30-day Notice |
| S003 | ||
| S002 | 2005-03-23 | 30-day Notice |
| S001 | 2002-11-15 | Special (immediate Track) |