Biotrin Parvovirus B19 Igg

FDA premarket approval P970054 · Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

PMA numberP970054

Approval

Applicant
Diasorin
Received
August 28, 1997
Decision date
August 6, 1999 (APPR)
Supplements
18, latest January 6, 2025
Product code
MYL – Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

Official FDA PMA record

Approval order statement

This device is indicated for: The Biotrin Parvovirus B19 IgG Enzyme Immunoassay is intended for the qualitative detection of IgG antibodies to B19 virus (B19V, previously known as human parvovirus B19) in human serum, lithium heparin, EDTA, and citrated plasma. This test, in conjunction w/the Biotrin Parvovirus B19 IgM 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 tomake 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).