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FDA PMA

Assay, 酶連接免疫攝取,乙型肝炎病毒

PMA 核准號:P010021 · 2020-08-07

決定日期2020-08-07
PMA 編號P010021
產品代碼MZO
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, enzyme linked immunosorbent, hepatitis c virus is the device name listed in this FDA 510(k) record. The listed applicant is Ortho-Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 2020-08-07. The device is classified under product code MZO. It was reviewed by the MI advisory panel.

常見問題

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 2020-08-07. The listed applicant is Ortho-Clinical Diagnostics, 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 Ortho-Clinical Diagnostics, 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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