ASSAY, 酶聯免疫吸附，B19 痘病毒 IGM
PMA 核准號：P150042 · 2017-09-19
廣告
決定日期2017-09-19
PMA 編號P150042
產品代碼MYM
器械分類3 類
醫療專科U
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,PARVOVIRUS B19 IGM is the device name listed in this FDA 510(k) record. The listed applicant is Zeus Scientific, Inc.. It received FDA 510(k) clearance on 2017-09-19. The device is classified under product code MYM. It was reviewed by the MI advisory panel.
常見問題
What is the ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM?
ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM is a medical device that received FDA 510(k) clearance on 2017-09-19. The listed applicant is Zeus Scientific, Inc..
When did ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM receive FDA 510(k) clearance?
The clearance date for ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM can be found in the official FDA records.
Who is the listed applicant for ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM?
The FDA 510(k) record lists Zeus Scientific, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM?
The FDA product code for ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM is MYM.
相關臨床試驗
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。
廣告