PMA P150042
- Device
- ZEUS ELISA PARVOVIRUS B19 IGM TEST SYSTEM
- Applicant
- Zeus Scientific, Inc.
- PMA number
- P150042
- Product code
- MYM
- Decision date
- 2017-09-19
- Generic name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM
- Approval order statement
- 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.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf15/P150042B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- ZEUS ELISA PARVOVIRUS B19 IGM TEST SYSTEM
- Applicant
- Zeus Scientific, Inc.
- PMA number
- P150042
- Product code
- MYM
- Generic name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM
- Decision date
- 2017-09-19
- Decision code
- APPR
- Date received
- 2015-11-19
- Approval order statement
- 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.