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FDA PMA

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

PMA Number: P990038 · 2021-12-21

ApplicantDiaSorin, Inc.
Decision Date2021-12-21
PMA NumberP990038
Product CodeLOM
Device ClassClass 2
Medical SpecialtyM
Regulation Number21 CFR 8
Advisory CommitteeMI

Device Summary

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2021-12-21. The device is classified under product code LOM. It was reviewed by the MI advisory panel.

Frequently Asked Questions

What is the Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)?

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) is a medical device that received FDA 510(k) clearance on 2021-12-21. The listed applicant is DiaSorin, Inc..

When did Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) receive FDA 510(k) clearance?

The clearance date for Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) can be found in the official FDA records.

Who is the listed applicant for Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)?

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 Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)?

The FDA product code for Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) is LOM.

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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