醫療器械
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各相關單位：
我單位正開展EB 病毒衣殼抗原 IgA 抗體國家參考品的換批研制工作，現邀請已經獲得EB 病毒衣殼抗原 IgA 抗體診斷試劑注冊證、或正進行EB 病毒衣殼抗原 IgA 抗體診斷試劑研發的企業參與標定工作。請有意向的境內上述企業或境外企業的中國代理人于2022年02月28日前報名參加，具體信息請填寫報名調研表（見附件）。
備注：如報名調研表信息填寫不完整或有遺漏，將導致無法參加本次標定工作。
聯系人：麻婷婷，周海衛 聯系電話：010-67095450，010-67095776
郵箱:matingting@nifdc.org.cn。
附件：報名調研表
中檢院
2022 年2月14日
【附件】
| 序號 | 企業名稱 | 產品名稱 | 注冊證號 | 方法學 | 檢測樣本類型（血清、血清+血漿、血漿...） | 包被抗原類型及名稱（重組/天然，P18/P23或其他） | 提供陽性判斷值確定資料（單獨文檔，可參考申報要求） | 單次加樣量（實際用量） | 死腔體積 | 聯系人 | 聯系電話 | 聯系郵箱 | 微信號 | 收樣地址 |
掃描下方的二維碼訂閱“ CIRS醫械合規動態 ”！實時傳遞最新醫療器械監管法規動態，分享醫療器械注冊成功經驗及經典案例跟蹤醫療器械最新產品安全與法規監管動態，獲得最新一手資訊。
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