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FDA 510(k)

雷昂尼克STI三重試驗，雷昂尼克EncompassMDx工作站（儀器和軟件），雷昂尼克尿液標本收集套件

K 號：K193081 · 2021-12-17

申請人Rheonix, Inc.
決定日期2021-12-17
產品代碼QEP
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

Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit is the device name listed in this FDA 510(k) record. The listed applicant is Rheonix, Inc.. It received FDA 510(k) clearance on 2021-12-17 under 510(k) number K193081. The device is classified under product code QEP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit?

Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit is a medical device that received FDA 510(k) clearance on 2021-12-17. The listed applicant is Rheonix, Inc.. The 510(k) number is K193081.

When did Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit receive FDA 510(k) clearance?

Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit received FDA 510(k) clearance on 2021-12-17, under 510(k) number K193081.

Who is the listed applicant for Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit?

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

What is the FDA product code for Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit?

The FDA product code for Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit is QEP.

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：QEP）

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。

K260917cobas CT/NG用於cobas 5800/6800/8800系統；cobas TV/MG用於cobas 5800/6800/8800系統Roche Molecular Systems, Inc.K253756cobas liat CT/NG 遺傳子測試Roche Molecular Systems, Inc.K253759cobas liat CT/NG/MG 遺傳子測試Roche Molecular Systems, Inc.K251501維斯比醫療男性性健康檢測Visby Medical, Inc.K243343BD CTGCTV2Bd Integrated Diagnostic Solutions/Becton,K240217cobas® liat CT/NG 遺傳子測試Roche Molecular Systems, Inc.

官方來源

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