FDA 510(k)

VITEK REVEAL GN AST 測試與VITEK REVEAL AST 系統

K 號：K260160 · 2026-07-08

決定日期2026-07-08

產品代碼SAN

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

VITEK REVEAL GN AST Assay and VITEK REVEAL AST System is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2026-07-08 under 510(k) number K260160. The device is classified under product code SAN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VITEK REVEAL GN AST Assay and VITEK REVEAL AST System?

VITEK REVEAL GN AST Assay and VITEK REVEAL AST System is a medical device that received FDA 510(k) clearance on 2026-07-08. The listed applicant is bioMerieux, Inc.. The 510(k) number is K260160.

When did VITEK REVEAL GN AST Assay and VITEK REVEAL AST System receive FDA 510(k) clearance?

VITEK REVEAL GN AST Assay and VITEK REVEAL AST System received FDA 510(k) clearance on 2026-07-08, under 510(k) number K260160.

Who is the listed applicant for VITEK REVEAL GN AST Assay and VITEK REVEAL AST System?

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

What is the FDA product code for VITEK REVEAL GN AST Assay and VITEK REVEAL AST System?

The FDA product code for VITEK REVEAL GN AST Assay and VITEK REVEAL AST System is SAN.

其他以 bioMerieux, 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。

K260282VITEK 2 AST-引起性青銅色球菌克林達霉素抗藥性 K251579VITEK 2 AST-革蘭氏陰性細菌頭孢噻呋（=<1-=>32 µg/mL）K234012VITEK 精簡型 PRO K232967VITEK 2 AST-酵母伏立康唑（<= 0.03125 - >= 4 µg/mL）K232963VITEK 2 AST-酵母阿尼霉素（<= 0.015 - >= 8 µg/mL）K240279VIDAS TBI (GFAP, UCH-L1)

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相關器械（代碼：SAN）

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。

K253316PhAST儀器及PhAST血液培養革蘭氏陰性細菌試劑板Phast Corp.K253573ASTar BC G- KitQ-Linea AB K251875LifeScale 革蘭氏細菌檢測套件（LSGN）搭配 LifeScale AST 系統Affinity Biosensors, LLC K241324LifeScale 革蘭氏細菌檢測套件（LSGN）搭配 LifeScale AST 系統Affinity Biosensors, LLC K230675VITEK REVEAL GN AST 測試與VITEK REVEAL AST 系統Specific Diagnostics, LLC K221688ASTar BC G- Kit 和 ASTar 器材Q-Linea AB

官方來源

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