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Parvovirus B19 IgM Enzyme Immunoassay (V619IMUS)

FDA PMA

Class III (US FDA PMA)

PMA P970055

by Diasorin

Identity

Trade Name
BIOTRIN PARVOVIRUS IGM EIA (V619IMUS) FDA PMA
Generic Name
ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM FDA PMA

Identifiers

PMA Number
P970055 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 Parvovirus B19 IgM Enzyme Immunoassay (V619IMUS) is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgM antibodies to parvovirus B19 (B19V) in human serum, lithium heparin, EDTA, and citrated plasma. It aids in identifying recent or current infection with B19V, supporting diagnostic evaluation for conditions such as fifth disease (erythema infectiosum).

This assay is intended for laboratory use and requires human samples collected in specified anticoagulants. Supplied as a single-use reagent kit, it operates under non-sterile conditions and does not require sterilisation. The device is classified as Class III under FDA regulations and is authorised under PMA number P970055. No MRI safety or reusable components are applicable to this diagnostic test.

Frequently asked questions

What is the purpose of the Parvovirus B19 IgM Enzyme Immunoassay?

This assay is designed for the qualitative detection of IgM antibodies to parvovirus B19 in human serum and plasma samples. It aids in identifying recent or current B19V infection and supports diagnostic evaluation for conditions like fifth disease.

What sample types can be used with this diagnostic test?

The test accepts human serum, lithium heparin, EDTA, and citrated plasma samples. These must be collected using the specified anticoagulants for proper analysis.

Is this device reusable or single-use?

The Parvovirus B19 IgM Enzyme Immunoassay is supplied as a single-use reagent kit and operates under non-sterile conditions without requiring sterilization.

How can this test be used in clinical practice?

This test can help diagnose fifth disease and may be used with the Biotrin Parvovirus B19 IgG test to determine serological status in women of childbearing age who may have been exposed to B19V.

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

Sources (1)

  • FDA PMA P970055 23 fields · synced Sep 18, 2026