Fastplex™ BCR-ABL (p210) %IS 適用性數字PCR試劑套件
K 號：K252243 · 2026-07-02
廣告
器材摘要
Fastplex™ BCR-ABL (p210) %IS digital PCR Kit is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Precigenome, Ltd. Co;. It received FDA 510(k) clearance on 2026-07-02 under 510(k) number K252243. The device is classified under product code OYX. It was reviewed by the MG advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Fastplex™ BCR-ABL (p210) %IS digital PCR Kit?
Fastplex™ BCR-ABL (p210) %IS digital PCR Kit is a medical device that received FDA 510(k) clearance on 2026-07-02. The listed applicant is Suzhou Precigenome, Ltd. Co;. The 510(k) number is K252243.
When did Fastplex™ BCR-ABL (p210) %IS digital PCR Kit receive FDA 510(k) clearance?
Fastplex™ BCR-ABL (p210) %IS digital PCR Kit received FDA 510(k) clearance on 2026-07-02, under 510(k) number K252243.
Who is the listed applicant for Fastplex™ BCR-ABL (p210) %IS digital PCR Kit?
The FDA 510(k) record lists Suzhou Precigenome, Ltd. Co; as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Fastplex™ BCR-ABL (p210) %IS digital PCR Kit?
The FDA product code for Fastplex™ BCR-ABL (p210) %IS digital PCR Kit is OYX.
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。
相關器械（代碼：OYX）
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。
K221869BCR-ABL1 (p210) % IS Kit (數位PCR方法)Suzhou Sniper Medical Technologies Co., Ltd.K190076Xpert BCR-ABL Ultra、GeneXpert Dx 系統、GeneXpert Infinity-48s 及 GeneXpert Infinity-80 系統CepheidK181661QXDx BCR-ABL %IS Kit，用於QXDx AutoDG ddPCR系統Bio-Rad Laboratories, Inc.K173492MRDx BCR-ABL 測試，MRDx BCR-ABL 測試軟體Molecularmd Corporation
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