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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceZEUS ELISA PARVOVIRUS B19 IGG TEST SYSTEM
Generic NameASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG
ApplicantZeus Scientific, Inc.
200 Evans Way
Branchburg, NJ 08876
PMA NumberP150045
Date Received11/24/2015
Decision Date09/19/2017
Product Code MYL 
Docket Number 17M-5864
Notice Date 09/22/2017
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the ZEUS ELISA Parvovirus B19 IgG Test System is intended for the qualitative detection of IgG 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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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