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FDA 510(k)

NOVEOS 特定IgE (sIgE) 測試；捕獲劑 G010，高梁（Sorghum halepense）；捕獲劑 T007，橡樹（Quercus alba）；捕獲劑 G002，百慕達草（Cynodon dactylon）；捕獲劑 W001，普通豚草（Ambrosia artemisiifolia）；捕獲劑 E005，狗糞（Canis familiaris）；捕獲劑 T003，普通銀樹（Betula verrucosa）；捕獲劑 F001，雞蛋白（Gallus gallus）；捕獲劑 F002，牛乳（Bos taurus）；NOVEOS 免疫分析

K 號：K242531 · 2025-04-23

申請人Hycor Biomedical
決定日期2025-04-23
產品代碼DHB
諮詢委員會此醫療器材為一項用於治療[疾病名稱]之裝置，已通過美國食品藥物管理局（FDA）之510(k)上市前通知程序，並取得[產品名稱]之上市許可。本裝置亦已獲得PMA（上市前核准）之認可，相關臨床試驗資料已登錄於ClinicalTrials.gov（NCT編號：[NCT號碼]），並已發表於經同儕審查之醫學期刊（PMID：[PMID號碼]）。更多詳細資訊請參閱：[URL]。
決定相當於

器材摘要

NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz is the device name listed in this FDA 510(k) record. The listed applicant is Hycor Biomedical. It received FDA 510(k) clearance on 2025-04-23 under 510(k) number K242531. The device is classified under product code DHB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz?

NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz is a medical device that received FDA 510(k) clearance on 2025-04-23. The listed applicant is Hycor Biomedical. The 510(k) number is K242531.

When did NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz receive FDA 510(k) clearance?

NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz received FDA 510(k) clearance on 2025-04-23, under 510(k) number K242531.

Who is the listed applicant for NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz?

FDA 510(k) 記錄將 Hycor Biomedical 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz?

The FDA product code for NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz is DHB.

相關臨床試驗

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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

其他以 Hycor Biomedical 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。

K261027NOVEOS 特异性IgE（sIgE）；捕獲劑 F014，大豆（Glycine max）；捕獲劑 F017，胡桃（Corylus avellana）；捕獲劑 F352，Ara h 8 PR-10，花生；捕獲劑 F423，Ara h 2，花生；捕獲劑 F447，Ara h 6，花生K260591NOVEOS 特异性IgE（sIgE）；捕獲劑 F010，芝麻（Sesamum indicum）；捕獲劑 F020，杏仁（Amygdalus communis）；捕獲劑 F078，Bos d 8 乳清蛋白，牛奶；捕獲劑 F080，蝦（Homarus gammarus）；捕獲劑 F422，Ara h 1，花生K260280NOVEOS 特异性IgE（sIgE）；捕獲劑 F004，麥（Triticum aestivum）；捕獲劑 F023，蟹（Callinectes spp.）；捕獲劑 F079，麩質，麥；捕獲劑 F202，腰果（Anacardium occidentale）；捕獲劑 F233，Gal d 1 蛋白質粘蛋白K260059NOVEOS 特异性IgE（sIgE）；捕集劑F018，巴西胡桃（Bertholletia excelsa）；捕集劑F036，椰子（Cocos nucifera）；捕集劑F040，鮪魚（Thunnus sp.）；捕集劑F041，鮭魚（Salmo salar）；捕集劑F075，雞黃（Gallus gallus）；捕集劑F201，核桃（Carya illinoensis）；捕集劑F203，開心果（Pistacia vera）；捕集劑F290，牡蠣（Ostrea edulis）K252775NOVEOS 特定IgE (sIgE)：捕獲劑 F013，花生（Arachis hypogaea）；捕獲劑 F076，Bos d 4 α-乳清蛋白，牛奶；捕獲劑 F077，Bos d 5 β-乳球蛋白，牛奶；捕獲劑 F232，Gal d 2 卵白蛋白，雞蛋K252493NOVEOS 特异性IgE（sIgE）；捕獲劑 F024，蝦（蝦 spp.）；捕獲劑 F207，蛤蜊（Mercenaria mercenaria）；捕獲劑 F256，胡桃（Juglans spp.）；捕獲劑 I006，德國蟑螂（Blatella germanica）

查看所有 11 項裝置 →

相關器械（代碼：DHB）

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。

K260331IMMULITE 2000 3g過敏特異性IgE Vantage；IMMULITE 2000 系統花生過敏原（F13）Siemens Healthcare Diagnostics Products, Ltd.K261027NOVEOS 特异性IgE（sIgE）；捕獲劑 F014，大豆（Glycine max）；捕獲劑 F017，胡桃（Corylus avellana）；捕獲劑 F352，Ara h 8 PR-10，花生；捕獲劑 F423，Ara h 2，花生；捕獲劑 F447，Ara h 6，花生Hycor BiomedicalK260591NOVEOS 特异性IgE（sIgE）；捕獲劑 F010，芝麻（Sesamum indicum）；捕獲劑 F020，杏仁（Amygdalus communis）；捕獲劑 F078，Bos d 8 乳清蛋白，牛奶；捕獲劑 F080，蝦（Homarus gammarus）；捕獲劑 F422，Ara h 1，花生Hycor BiomedicalK260280NOVEOS 特异性IgE（sIgE）；捕獲劑 F004，麥（Triticum aestivum）；捕獲劑 F023，蟹（Callinectes spp.）；捕獲劑 F079，麩質，麥；捕獲劑 F202，腰果（Anacardium occidentale）；捕獲劑 F233，Gal d 1 蛋白質粘蛋白Hycor BiomedicalK260059NOVEOS 特异性IgE（sIgE）；捕集劑F018，巴西胡桃（Bertholletia excelsa）；捕集劑F036，椰子（Cocos nucifera）；捕集劑F040，鮪魚（Thunnus sp.）；捕集劑F041，鮭魚（Salmo salar）；捕集劑F075，雞黃（Gallus gallus）；捕集劑F201，核桃（Carya illinoensis）；捕集劑F203，開心果（Pistacia vera）；捕集劑F290，牡蠣（Ostrea edulis）Hycor BiomedicalK252775NOVEOS 特定IgE (sIgE)：捕獲劑 F013，花生（Arachis hypogaea）；捕獲劑 F076，Bos d 4 α-乳清蛋白，牛奶；捕獲劑 F077，Bos d 5 β-乳球蛋白，牛奶；捕獲劑 F232，Gal d 2 卵白蛋白，雞蛋Hycor Biomedical

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