Approval for the zeus elisa parvovirus b19 igm test system is intended for the qualitative detection of igm class antibodies to human parvovirus b19 in human serum including women of childbearing age where there is a suspicion of exposure to human parvovirus b19. The test is also for all symptomatic patients as an aid in the diagnosis of fifth disease (erythema infectiosum). This test is for in vitro diagnostic use only.
| Device | ZEUS ELISA PARVOVIRUS B19 IGM TEST SYSTEM |
| Generic Name | Assay,enzyme Linked Immunosorbent,parvovirus B19 Igm |
| Applicant | ZEUS SCIENTIFIC, INC. |
| Date Received | 2015-11-19 |
| Decision Date | 2017-09-19 |
| Notice Date | 2017-09-22 |
| PMA | P150042 |
| Supplement | S |
| Product Code | MYM |
| Docket Number | 17M-5863 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ZEUS SCIENTIFIC, INC. 200 Evans Way branchburg, NJ 08876 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P150042 | Original Filing |