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FDA PMA

試劑,基因分類,乙型肝炎C病毒

PMA 核准號:P120012 · 2021-03-05

決定日期2021-03-05
PMA 編號P120012
產品代碼OBF
器械分類2 類
醫療專科M
法規編號21 CFR 8
諮詢委員會MI (請提供完整的描述文本,以便進行翻譯。)

器材摘要

Assay, genotyping, hepatitis c virus is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Molecular. It received FDA 510(k) clearance on 2021-03-05. The device is classified under product code OBF. It was reviewed by the MI advisory panel.

常見問題

What is the Assay, genotyping, hepatitis c virus?

Assay, genotyping, hepatitis c virus is a medical device that received FDA 510(k) clearance on 2021-03-05. The listed applicant is Abbott Molecular.

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 Abbott Molecular 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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