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LIAISON Biotrin Parvovirus B19 IgM Plus, LIAISON Biotrin Control Parvovirus B19 IgM Plus

FDA PMA

Class III (US FDA PMA)

PMA P250039

by Diasorin Inc.

Identity

Trade Name
LIAISON Biotrin Parvovirus B19 IgM Plus, LIAISON Biotrin Control Parvovirus B19 IgM Plus FDA PMA
Generic Name
ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM FDA PMA

Identifiers

PMA Number
P250039 FDA PMA
FDA Product Code
MYM FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Microbiology FDA PMA
FDA Decision
APPR Approved FDA PMA

The LIAISON Biotrin Parvovirus B19 IgM Plus is a chemiluminescent immunoassay (CLIA) designed for the qualitative detection of IgM antibodies to human parvovirus B19 in human serum, lithium heparin, K2-EDTA, and sodium citrate plasma. Classified as an enzyme-linked immunosorbent assay (ELISA), this device aids in determining serological status for parvovirus B19 exposure, distinguishing between past, recent, or current infection.

This assay is performed exclusively on the LIAISON XL Analyzer and is supplied as a single-use reagent kit. The LIAISON Biotrin Control Parvovirus B19 IgM Plus serves as a quality control companion. The device holds FDA_PMA authorization under PMA number P250039 and is categorized under device class 3 (MYM product code). No additional regulatory status or sterility claims are specified in the data.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Diasorin Inc.
FDA Applicant
DiaSorin, Inc.

Sources (1)

  • FDA PMA P250039 24 fields · synced Sep 18, 2026