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FDA PMA

ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM

PMA Number: P970055 · 2025-01-06

ApplicantDiasorin
Decision Date2025-01-06
PMA NumberP970055
Product CodeMYM
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeMI

Device Summary

ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM is the device name listed in this FDA 510(k) record. The listed applicant is Diasorin. It received FDA 510(k) clearance on 2025-01-06. The device is classified under product code MYM. It was reviewed by the MI advisory panel.

Frequently Asked Questions

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

ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM is a medical device that received FDA 510(k) clearance on 2025-01-06. The listed applicant is Diasorin.

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

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

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

The FDA 510(k) record lists Diasorin 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 IGM?

The FDA product code for ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM is MYM.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

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

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