{"id":2120,"date":"2024-10-09T14:26:00","date_gmt":"2024-10-09T14:26:00","guid":{"rendered":"https:\/\/moneycompass.com.my\/cn\/healgen-scientific%e8%8e%b7%e5%be%97fda-de-novo%e4%b8%8a%e5%b8%82%e8%ae%b8%e5%8f%af\/"},"modified":"2024-10-09T14:26:00","modified_gmt":"2024-10-09T14:26:00","slug":"healgen-scientific%e8%8e%b7%e5%be%97fda-de-novo%e4%b8%8a%e5%b8%82%e8%ae%b8%e5%8f%af","status":"publish","type":"post","link":"https:\/\/moneycompass.com.my\/cn\/healgen-scientific%e8%8e%b7%e5%be%97fda-de-novo%e4%b8%8a%e5%b8%82%e8%ae%b8%e5%8f%af\/","title":{"rendered":"Healgen Scientific\u83b7\u5f97FDA De Novo\u4e0a\u5e02\u8bb8\u53ef"},"content":{"rendered":"<p>Healgen Rapid Check \u00ae  COVID-19\/A\u578b\u53caB\u578b\u6d41\u611f\u6297\u539f\u68c0\u6d4b\u5f97\u5230\u4e86\u56fd\u7acb\u536b\u751f\u7814\u7a76\u9662\uff08NIH\uff09\u5feb\u901f\u8bca\u65ad\u52a0\u901f\uff08RADx \u00ae 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href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=zh-hans&amp;o=4272834-1&amp;h=4231831672&amp;u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4272834-1%26h%3D2500292708%26u%3Dhttps%253A%252F%252Fwww.fda.gov%252Fnews-events%252Fpress-announcements%252Ffda-authorizes-marketing-first-home-flu-and-covid-19-combination-test-outside-emergency-use%26a%3DClick%2Bhere%2Bfor%2BFDA%2BRelease.&amp;a=%E7%82%B9%E5%87%BB%E6%AD%A4%E5%A4%84%E6%9F%A5%E7%9C%8BFDA%E5%85%AC%E5%91%8A%E3%80%82\" target=\"_blank\" rel=\"noopener\">\u70b9\u51fb\u6b64\u5904\u67e5\u770bFDA\u516c\u544a\u3002<\/a> FDA\u7684De Novo\u8def\u5f84\u4e13\u4e3a\u90a3\u4e9b\u6ca1\u6709\u5408\u6cd5\u4e0a\u5e02\u5bf9\u7167\u5668\u68b0\u7684\u533b\u7597\u5668\u68b0\u8bbe\u8ba1\uff0c\u5b83\u4e3a\u5f00\u53d1\u65b0\u7684\u5668\u68b0\u5206\u7c7b\u63d0\u4f9b\u4e86\u72ec\u7279\u673a\u4f1a\uff0c\u4ee5\u6539\u5584\u60a3\u8005\u62a4\u7406\u548c\u6cbb\u7597\u7ed3\u679c\u3002<\/p>\n<div><\/div>\n<p>Healgen Rapid Check\u00ae COVID-19\/A\u578b\u53caB\u578b\u6d41\u611f\u6297\u539f\u68c0\u6d4b\u662f\u4e00\u79cd\u975e\u5904\u65b9\uff08OTC\uff09\u4ea7\u54c1\uff0c\u53ef\u5feb\u901f\u3001\u51c6\u786e\u3001\u4fbf\u6377\u5730\u68c0\u6d4bCOVID-19\u3001\u7532\u578b\u6d41\u611f\u548c\u4e59\u578b\u6d41\u611f\u7684\u611f\u67d3\u60c5\u51b5\u3002 \u201c\u6211\u4eec\u7684\u7ec4\u5408\u68c0\u6d4b\u901a\u8fc7\u4e3a\u4e2a\u4eba\u63d0\u4f9b\u53ef\u9760\u4e14\u6613\u4e8e\u4f7f\u7528\u7684\u5c45\u5bb6\u81ea\u6d4b\u89e3\u51b3\u65b9\u6848\uff0c\u586b\u8865\u4e86\u4e34\u5e8a\u8bca\u65ad\u68c0\u6d4b\u4e2d\u7684\u4e00\u4e2a\u91cd\u8981\u7a7a\u767d\u3002\u201dHealgen\u9996\u5e2d\u6267\u884c\u5b98Bingliang Fang\u535a\u58eb\u8868\u793a\u3002 \u201c\u65e9\u671f\u8bca\u65ad\u53ef\u4ee5\u66f4\u5feb\u5730\u542f\u52a8\u9002\u5f53\u6cbb\u7597\uff0c\u4ece\u800c\u6539\u5584\u5065\u5eb7\u72b6\u51b5\u5e76\u51cf\u5c11\u75be\u75c5\u4f20\u64ad\u3002\u201d<\/p>\n<p>Healgen\u5c45\u5bb6\u68c0\u6d4b\u6570\u636e\u7684\u9a8c\u8bc1\u5f97\u5230\u4e86\u72ec\u7acb\u68c0\u6d4b\u8bc4\u4f30\u8ba1\u5212\uff08ITAP\uff09\u7684\u652f\u6301\uff0c\u8fd9\u662f\u56fd\u7acb\u536b\u751f\u7814\u7a76\u9662\uff08NIH\uff09\u5feb\u901f\u8bca\u65ad\u52a0\u901f\uff08RADx\u00ae\uff09\u6280\u672f\u9879\u76ee\u7684\u4e00\u90e8\u5206\u3002 ITAP\u8bc4\u4f30\u4e86Healgen Rapid Check COVID-19\/A\u578b\u53caB\u578b\u6d41\u611f\u6297\u539f\u68c0\u6d4b\u7684\u8d28\u91cf\u3001\u51c6\u786e\u6027\u548c\u53ef\u9760\u6027\uff0c\u53d1\u73b0\u5176\u7075\u654f\u5ea6\u548c\u7279\u5f02\u6027\u5206\u522b\u5927\u4e8e90%\u548c99%\u3002 \u201cHealgen\u83b7\u5f97\u7684\u8fd9\u9879De Novo\u4e0a\u5e02\u8bb8\u53ef\u5f70\u663e\u4e86RADx Tech\u8ba1\u5212\u548cITAP\u5728\u52a0\u901f\u5bb6\u5ead\u68c0\u6d4b\u6388\u6743\u65b9\u9762\u7684\u6210\u5c31\uff0c\u5e76\u4e14\u968f\u7740\u6211\u4eec\u8fdb\u5165\u79cb\u5b63\u547c\u5438\u9053\u75c5\u6bd2\u5b63\u8282\uff0c\u5b83\u5c06\u6210\u4e3a\u516c\u5171\u536b\u751f\u89e3\u51b3\u65b9\u6848\u4e2d\u7684\u4e00\u4e2a\u91cd\u8981\u90e8\u5206\u3002\u201dVentureWell\u5546\u4e1a\u5316\u4e1a\u52a1\u526f\u603b\u88c1Rebekah Neal\u8868\u793a\u3002 \u201cVentureWell\u5f88\u8363\u5e78\u80fd\u4f5c\u4e3aNIH\/NIBIB\u521b\u65b0\u6f0f\u6597\u5546\u4e1a\u5316\u4e2d\u5fc3\u5728\u8fd9\u6b21\u5408\u4f5c\u4e2d\u53d1\u6325\u4f5c\u7528\u3002\u201d<\/p>\n<p>\u901a\u8fc7\u7b80\u5355\u7684\u9f3b\u62ed\u5b50\uff0c\u4e2a\u4eba\u53ef\u4ee5\u5feb\u901f\u786e\u5b9a\u4ed6\u4eec\u7684\u75c7\u72b6\u662f\u7531COVID-19\u3001\u7532\u578b\u6d41\u611f\u8fd8\u662f\u4e59\u578b\u6d41\u611f\u5f15\u8d77\u3002\u8fd9\u6d88\u9664\u4e86\u591a\u6b21\u68c0\u6d4b\u7684\u5fc5\u8981\uff0c\u5e76\u51cf\u8f7b\u4e86\u533b\u7597\u4fdd\u5065\u7cfb\u7edf\u7684\u8d1f\u62c5\u3002 Healgen Rapid Check COVID-19\/A\u578b\u53caB\u578b\u6d41\u611f\u6297\u539f\u68c0\u6d4b\u9002\u7528\u4e8e14\u5c81\u53ca\u4ee5\u4e0a\u4eba\u7fa4\uff0c\u6216\u7531\u6210\u4eba\u6536\u96c6\u76842\u5c81\u53ca\u4ee5\u4e0a\u4eba\u7fa4\u7684\u6837\u672c\uff0c\u7528\u4e8e\u5728\u75c7\u72b6\u51fa\u73b0\u7684\u5934\u4e94\u5929\u5185\u8fdb\u884c\u68c0\u6d4b\u3002<\/p>\n<p>\u201cDe Novo\u7684\u8fd9\u4e00\u6388\u6743\u662fHealgen\u7684\u4e00\u4e2a\u91cd\u8981\u91cc\u7a0b\u7891\u3002 \u51ed\u501f\u6211\u4eec\u73b0\u6709\u7684\u5c16\u7aef\u5236\u9020\u8bbe\u65bd\uff0c\u6211\u4eec\u8ba1\u5212\u6269\u5927\u547c\u5438\u68c0\u6d4b\u4ea7\u54c1\u7684\u751f\u4ea7\uff0c\u4ee5\u6ee1\u8db3\u5373\u5c06\u5230\u6765\u7684\u79cb\u5b63\u547c\u5438\u9053\u75be\u75c5\u9ad8\u53d1\u5b63\u8282\u7684\u5168\u7403\u9700\u6c42\u3002\u201dHealgen\u603b\u88c1Bryan Fang\u8868\u793a\u3002<\/p>\n<p>Healgen\u5bf9\u8d28\u91cf\u548c\u521b\u65b0\u7684\u627f\u8bfa\u5728Healgen Rapid Check COVID-19\/A\u578b\u53caB\u578b\u6d41\u611f\u6297\u539f\u68c0\u6d4b\u7684\u4e25\u683c\u5f00\u53d1\u4e0e\u9a8c\u8bc1\u8fc7\u7a0b\u4e2d\u5f97\u5230\u4e86\u5145\u5206\u4f53\u73b0\u3002 \u8be5\u68c0\u6d4b\u65e8\u5728\u6ee1\u8db3\u6700\u9ad8\u6027\u80fd\u6807\u51c6\uff0c\u5305\u62ec\u51c6\u786e\u6027\u3001\u53ef\u9760\u6027\u548c\u6613\u7528\u6027\uff0c\u786e\u4fdd\u4e2a\u4eba\u53ef\u4ee5\u4fe1\u4efb\u4ed6\u4eec\u6536\u5230\u7684\u7ed3\u679c\u3002<\/p>\n<p>\u8be5\u9879\u76ee\u7531\u7f8e\u56fd\u56fd\u5bb6\u751f\u7269\u533b\u5b66\u6210\u50cf\u548c\u751f\u7269\u5de5\u7a0b\u7814\u7a76\u6240\uff08NIBIB\uff09\u3001\u56fd\u7acb\u536b\u751f\u7814\u7a76\u9662\u3001\u7f8e\u56fd\u536b\u751f\u4e0e\u516c\u4f17\u670d\u52a1\u90e8\u8d44\u52a9\uff0c\u5408\u540c\u7f16\u53f7\u4e3a 75N92022D00010\u548c75N92022D00013\u3002<\/p>\n<p>\u5173\u4e8eHealgen<\/p>\n<p>Healgen Scientific, LLC\u81f4\u529b\u4e8e\u6539\u5584\u5168\u7403\u5065\u5eb7\u72b6\u51b5\uff0c\u662f\u9ad8\u8d28\u91cf\u533b\u7597\u4fdd\u5065\u4ea7\u54c1\u548c\u89e3\u51b3\u65b9\u6848\u7684\u9886\u5148\u4f9b\u5e94\u5546\u3002 Healgen\u4e13\u6ce8\u4e8e\u521b\u65b0\u3001\u8d28\u91cf\u548c\u53ef\u53ca\u6027\uff0c\u5f00\u53d1\u548c\u5546\u4e1a\u5316\u533b\u7597\u4fdd\u5065\u4ea7\u54c1\u548c\u89e3\u51b3\u65b9\u6848\uff0c\u52a9\u529b\u4e2a\u4eba\u548c\u533b\u7597\u4fdd\u5065\u63d0\u4f9b\u8005\u505a\u51fa\u660e\u667a\u7684\u60a3\u8005\u62a4\u7406\u51b3\u7b56\u3002 Healgen\u7684\u4f7f\u547d\u662f\u63d0\u5347\u5168\u7403\u5065\u5eb7\u6c34\u5e73\uff0c\u4e3a\u6240\u6709\u4eba\u521b\u9020\u4e00\u4e2a\u66f4\u5065\u5eb7\u7684\u4e16\u754c\u3002<\/p>\n<p>\u5982\u9700\u66f4\u591a\u4fe1\u606f\uff0c\u8bf7\u8bbf\u95ee<a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=zh-hans&amp;o=4272834-1&amp;h=439785566&amp;u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4272834-1%26h%3D3737592503%26u%3Dhttps%253A%252F%252Fwww.healgen.com%252F%26a%3DHealgen%2527s%2Bwebsite&amp;a=Healgen%E7%BD%91%E7%AB%99\" target=\"_blank\" rel=\"noopener\">Healgen\u7f51\u7ad9<\/a>\u6216\u8054\u7cfb<a href=\"mailto:media@healgen.com\" target=\"_blank\" rel=\"noopener\">media@healgen.com<\/a>\u8fdb\u884c\u5a92\u4f53\u54a8\u8be2\u3002 \u5ba3\u5e03\u8fd9\u4e00\u6d88\u606f\u7684\u65b0\u95fb\u7a3f\u53ef\u5728<a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=zh-hans&amp;o=4272834-1&amp;h=3256981179&amp;u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4272834-1%26h%3D436339929%26u%3Dhttps%253A%252F%252Fwww.fda.gov%252Fnews-events%252Fpress-announcements%252Ffda-authorizes-marketing-first-home-flu-and-covid-19-combination-test-outside-emergency-use%26a%3DFDA%2527s%2Bwebsite.&amp;a=FDA%E7%BD%91%E7%AB%99\" target=\"_blank\" rel=\"noopener\">FDA\u7f51\u7ad9<\/a>\u4e0a\u67e5\u9605\u3002<\/p>\n<p>Rapid Check\u00ae\u662fHealgen Scientific, LLC\u7684\u6ce8\u518c\u5546\u6807\u3002 RADx\u00ae\u662f\u7f8e\u56fd\u536b\u751f\u4e0e\u516c\u4f17\u670d\u52a1\u90e8\u7684\u6ce8\u518c\u5546\u6807\u3002<\/p>\n<div><\/div>\n<p>SOURCE  Healgen<\/p>","protected":false},"excerpt":{"rendered":"<p>Healgen Rapid Check \u00ae COVID-19\/A\u578b\u53caB\u578b\u6d41\u611f\u6297\u539f\u68c0\u6d4b\u5f97\u5230\u4e86\u56fd\u7acb\u536b\u751f\u7814\u7a76\u9662\uff08NIH\uff09\u5feb\u901f\u8bca\u65ad\u52a0\u901f\uff08RADx \u00ae \uff09\u6280\u672f\u9879\u76ee\u4e2d\u7684\u72ec\u7acb\u68c0\u6d4b\u8bc4\u4f30\u8ba1\u5212\uff08ITAP\uff09\u7684\u652f\u6301\u3002 \u4f11\u65af\u987f2024\u5e7410\u67089\u65e5 \/\u7f8e\u901a\u793e\/ &#8212; \u4f5c\u4e3a\u8bca\u65ad\u89e3\u51b3\u65b9\u6848\u7684\u9886\u5148\u521b\u65b0\u8005\uff0cHealgen Scientific LLC\u5ba3\u5e03U.S. Food and Drug Administration\uff08FDA\uff09\u5df2\u6388\u4e88Healgen Rapid Check\u00ae COVID-19\/A\u578b\u53caB\u578b\u6d41\u611f\u6297\u539f\u68c0\u6d4b\u975e\u5904\u65b9\uff08OTC\uff09\u4f7f\u7528\u7684De Novo\u4e0a\u5e02\u8bb8\u53ef\u3002\u00a0\u70b9\u51fb\u6b64\u5904\u67e5\u770bFDA\u516c\u544a\u3002 FDA\u7684De Novo\u8def\u5f84\u4e13\u4e3a\u90a3\u4e9b\u6ca1\u6709\u5408\u6cd5\u4e0a\u5e02\u5bf9\u7167\u5668\u68b0\u7684\u533b\u7597\u5668\u68b0\u8bbe\u8ba1\uff0c\u5b83\u4e3a\u5f00\u53d1\u65b0\u7684\u5668\u68b0\u5206\u7c7b\u63d0\u4f9b\u4e86\u72ec\u7279\u673a\u4f1a\uff0c\u4ee5\u6539\u5584\u60a3\u8005\u62a4\u7406\u548c\u6cbb\u7597\u7ed3\u679c\u3002 Healgen Rapid Check\u00ae COVID-19\/A\u578b\u53caB\u578b\u6d41\u611f\u6297\u539f\u68c0\u6d4b\u662f\u4e00\u79cd\u975e\u5904\u65b9\uff08OTC\uff09\u4ea7\u54c1\uff0c\u53ef\u5feb\u901f\u3001\u51c6\u786e\u3001\u4fbf\u6377\u5730\u68c0\u6d4bCOVID-19\u3001\u7532\u578b\u6d41\u611f\u548c\u4e59\u578b\u6d41\u611f\u7684\u611f\u67d3\u60c5\u51b5\u3002 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LLC\u5ba3\u5e03U.S. Food and Drug Administration\uff08FDA\uff09\u5df2\u6388\u4e88Healgen Rapid Check\u00ae COVID-19\/A\u578b\u53caB\u578b\u6d41\u611f\u6297\u539f\u68c0\u6d4b\u975e\u5904\u65b9\uff08OTC\uff09\u4f7f\u7528\u7684De Novo\u4e0a\u5e02\u8bb8\u53ef\u3002\u00a0\u70b9\u51fb\u6b64\u5904\u67e5\u770bFDA\u516c\u544a\u3002 FDA\u7684De Novo\u8def\u5f84\u4e13\u4e3a\u90a3\u4e9b\u6ca1\u6709\u5408\u6cd5\u4e0a\u5e02\u5bf9\u7167\u5668\u68b0\u7684\u533b\u7597\u5668\u68b0\u8bbe\u8ba1\uff0c\u5b83\u4e3a\u5f00\u53d1\u65b0\u7684\u5668\u68b0\u5206\u7c7b\u63d0\u4f9b\u4e86\u72ec\u7279\u673a\u4f1a\uff0c\u4ee5\u6539\u5584\u60a3\u8005\u62a4\u7406\u548c\u6cbb\u7597\u7ed3\u679c\u3002 Healgen Rapid Check\u00ae COVID-19\/A\u578b\u53caB\u578b\u6d41\u611f\u6297\u539f\u68c0\u6d4b\u662f\u4e00\u79cd\u975e\u5904\u65b9\uff08OTC\uff09\u4ea7\u54c1\uff0c\u53ef\u5feb\u901f\u3001\u51c6\u786e\u3001\u4fbf\u6377\u5730\u68c0\u6d4bCOVID-19\u3001\u7532\u578b\u6d41\u611f\u548c\u4e59\u578b\u6d41\u611f\u7684\u611f\u67d3\u60c5\u51b5\u3002 \u201c\u6211\u4eec\u7684\u7ec4\u5408\u68c0\u6d4b\u901a\u8fc7\u4e3a\u4e2a\u4eba\u63d0\u4f9b\u53ef\u9760\u4e14\u6613\u4e8e\u4f7f\u7528\u7684\u5c45\u5bb6\u81ea\u6d4b\u89e3\u51b3\u65b9\u6848\uff0c\u586b\u8865\u4e86\u4e34\u5e8a\u8bca\u65ad\u68c0\u6d4b\u4e2d\u7684\u4e00\u4e2a\u91cd\u8981\u7a7a\u767d\u3002\u201dHealgen\u9996\u5e2d\u6267\u884c\u5b98Bingliang Fang\u535a\u58eb\u8868\u793a\u3002 \u201c\u65e9\u671f\u8bca\u65ad\u53ef\u4ee5\u66f4\u5feb\u5730\u542f\u52a8\u9002\u5f53\u6cbb\u7597\uff0c\u4ece\u800c\u6539\u5584\u5065\u5eb7\u72b6\u51b5\u5e76\u51cf\u5c11\u75be\u75c5\u4f20\u64ad\u3002\u201d Healgen\u5c45\u5bb6\u68c0\u6d4b\u6570\u636e\u7684\u9a8c\u8bc1\u5f97\u5230\u4e86\u72ec\u7acb\u68c0\u6d4b\u8bc4\u4f30\u8ba1\u5212\uff08ITAP\uff09\u7684\u652f\u6301\uff0c\u8fd9\u662f\u56fd\u7acb\u536b\u751f\u7814\u7a76\u9662\uff08NIH\uff09\u5feb\u901f\u8bca\u65ad\u52a0\u901f\uff08RADx\u00ae\uff09\u6280\u672f\u9879\u76ee\u7684\u4e00\u90e8\u5206\u3002 ITAP\u8bc4\u4f30\u4e86Healgen Rapid Check COVID-19\/A\u578b\u53caB\u578b\u6d41\u611f\u6297\u539f\u68c0\u6d4b\u7684\u8d28\u91cf\u3001\u51c6\u786e\u6027\u548c\u53ef\u9760\u6027\uff0c\u53d1\u73b0\u5176\u7075\u654f\u5ea6\u548c\u7279\u5f02\u6027\u5206\u522b\u5927\u4e8e90%\u548c99%\u3002 \u201cHealgen\u83b7\u5f97\u7684\u8fd9\u9879De Novo\u4e0a\u5e02\u8bb8\u53ef\u5f70\u663e\u4e86RADx 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