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FDA PMA

Assay, enzyme linked immunosorbent, hepatitis c virus

PMA Number: P190011 · 2021-08-10

ApplicantDiaSorin, Inc.
Decision Date2021-08-10
PMA NumberP190011
Product CodeMZO
Device ClassClass 2
Medical SpecialtyM
Regulation Number21 CFR 8
Advisory CommitteeMI

Device Summary

Assay, enzyme linked immunosorbent, hepatitis c virus is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2021-08-10. The device is classified under product code MZO. It was reviewed by the MI advisory panel.

Frequently Asked Questions

What is the Assay, enzyme linked immunosorbent, hepatitis c virus?

Assay, enzyme linked immunosorbent, hepatitis c virus is a medical device that received FDA 510(k) clearance on 2021-08-10. The listed applicant is DiaSorin, Inc..

When did Assay, enzyme linked immunosorbent, hepatitis c virus receive FDA 510(k) clearance?

The clearance date for Assay, enzyme linked immunosorbent, hepatitis c virus can be found in the official FDA records.

Who is the listed applicant for Assay, enzyme linked immunosorbent, hepatitis c virus?

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, hepatitis c virus?

The FDA product code for Assay, enzyme linked immunosorbent, hepatitis c virus is MZO.

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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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