Assay, 酶連接免疫攝取，乙型肝炎病毒
PMA 核准號：P080027 · 2021-04-20
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決定日期2021-04-20
PMA 編號P080027
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 OraSure Technologies, Inc.. It received FDA 510(k) clearance on 2021-04-20. 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 2021-04-20. The listed applicant is OraSure Technologies, 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 OraSure Technologies, 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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官方來源
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