Biotrin Parvovirus Igm Eia (V619IMUS)

FDA premarket approval P970055 · Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

PMA numberP970055

Approval

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

Official FDA PMA record

Approval order statement

The device is intended for the qualitative detection if IgM antibodies to B19 virus (B19V, previously known as human parvovirus B19) in human seru, lithium heparin, EDTA, and citrated plasma. This test, in conjunction with the Biotrin Parvovirus B19 IgG 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 to make 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).