Zeus Elisa Parvovirus B19 Igm Test System

FDA premarket approval P150042 · Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

PMA numberP150042

Approval

Applicant
Zeus Scientific, Inc.
Received
November 19, 2015
Decision date
September 19, 2017 (APPR)
Supplements
0
Product code
MYM – Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

Official FDA PMA record

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.