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FDA PMA

ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG

PMA Number: P220034 · 2026-08-18

ApplicantDiaSorin, Inc.
Decision Date2026-08-18
PMA NumberP220034
Product CodeMYL
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeMI

Device Summary

ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2026-08-18. The device is classified under product code MYL. It was reviewed by the MI advisory panel.

Frequently Asked Questions

What is the ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG?

ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG is a medical device that received FDA 510(k) clearance on 2026-08-18. The listed applicant is DiaSorin, Inc..

When did ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG receive FDA 510(k) clearance?

The clearance date for ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG can be found in the official FDA records.

Who is the listed applicant for ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG?

The FDA 510(k) record lists DiaSorin, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG?

The FDA product code for ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG is MYL.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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