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FDA PMA

Assay, genotyping, hepatitis c virus

PMA Number: P160016 · 2020-09-23

ApplicantFujirebio Europe N.V.
Decision Date2020-09-23
PMA NumberP160016
Product CodeOBF
Device ClassClass 2
Medical SpecialtyM
Regulation Number21 CFR 8
Advisory CommitteeMI

Device Summary

Assay, genotyping, hepatitis c virus is the device name listed in this FDA 510(k) record. The listed applicant is Fujirebio Europe N.V.. It received FDA 510(k) clearance on 2020-09-23. The device is classified under product code OBF. It was reviewed by the MI advisory panel.

Frequently Asked Questions

What is the Assay, genotyping, hepatitis c virus?

Assay, genotyping, hepatitis c virus is a medical device that received FDA 510(k) clearance on 2020-09-23. The listed applicant is Fujirebio Europe N.V..

When did Assay, genotyping, hepatitis c virus receive FDA 510(k) clearance?

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

Who is the listed applicant for Assay, genotyping, hepatitis c virus?

The FDA 510(k) record lists Fujirebio Europe N.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Assay, genotyping, hepatitis c virus?

The FDA product code for Assay, genotyping, hepatitis c virus is OBF.

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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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