illumigene 計量枝原體直接DNA擴增試劑，illumigene 計量枝原體直接外部控制，illumipro-10
K 號：K160829 · 2016-06-13
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器材摘要
常見問題
What is the illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10?
illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 is a medical device that received FDA 510(k) clearance on 2016-06-13. The listed applicant is Meridian Bioscience, Inc.. The 510(k) number is K160829.
When did illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 receive FDA 510(k) clearance?
illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 received FDA 510(k) clearance on 2016-06-13, under 510(k) number K160829.
Who is the listed applicant for illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10?
The FDA 510(k) record lists Meridian Bioscience, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10?
The FDA product code for illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 is OZX.
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其他以 Meridian Bioscience, Inc. 為申請人之記錄
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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