FDA 510(k)

DNA/RNA保護盾安全收集唾液收集套件

K 號：K231013 · 2023-09-28

決定日期2023-09-28

產品代碼QBD

諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)

決定相當於

器材摘要

DNA/RNA Shield SafeCollect Saliva Collection kit is the device name listed in this FDA 510(k) record. The listed applicant is Zymo Research. It received FDA 510(k) clearance on 2023-09-28 under 510(k) number K231013. The device is classified under product code QBD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DNA/RNA Shield SafeCollect Saliva Collection kit?

DNA/RNA Shield SafeCollect Saliva Collection kit is a medical device that received FDA 510(k) clearance on 2023-09-28. The listed applicant is Zymo Research. The 510(k) number is K231013.

When did DNA/RNA Shield SafeCollect Saliva Collection kit receive FDA 510(k) clearance?

DNA/RNA Shield SafeCollect Saliva Collection kit received FDA 510(k) clearance on 2023-09-28, under 510(k) number K231013.

Who is the listed applicant for DNA/RNA Shield SafeCollect Saliva Collection kit?

The FDA 510(k) record lists Zymo Research as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DNA/RNA Shield SafeCollect Saliva Collection kit?

The FDA product code for DNA/RNA Shield SafeCollect Saliva Collection kit is QBD.

其他以 Zymo Research 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。

K202641DNA/RNA防護收樣管

相關器械（代碼：QBD）

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。

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官方來源

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