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Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit

产品名称：Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit
产品品牌：复星/FOSUN
产品分类：新冠病毒专栏（COVID-19）,检验科
卖家所在地：上海市 上海市
标准名称：Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit
产品来源：国产
产品俗称：Novel Coronavirus、nCov
注册类别：三类
生产厂家：Shanghai Fosun Med-Tech Development Co., Ltd.
产品类型：试剂
产品型号：48 tests/kit; 96 tests/kit
卖家公司：上海星耀医学科技发展有限公司

联系方式

姓名 负责地区 电话
陈
多城市 | 多省份
13817358225

上海星耀医学科技发展有限公司

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产品详细说明

产品名称： Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit
包装规格： 48 tests/kit; 96 tests/kit
China NMPA：

China FDA certificate number：

GUOXIEZHUZHUN 20203400299(国械注准20203400299)

CE Ref. No：

CE certification number

Ref. No.：GZ8821-2020

Order. No.：GZ8776-2020

Features：

Comprehensive: 3 targets (ORF1ab, N and E genes) detected in 1 tube

Reliable: Internal control, UNG enzyme and dUTP were used to reduce risk of  contamination and false positive results

Faster results: 1.5 hours post-extraction turnaround time

Sample Type：Nasopharyngeal swab/ Throat swab / Sputum/Stool

Instrument: Four-channel RT-PCR instrument(FAM/JOE/ROX/CY5)

P I：

Product information

Registration certificate: CE: Ref. No.: GZ 8821-2020

                                        China NMPA: GUOXIEZHUZHUN 20203400299

Specification: 48 tests/kit; 96 tests/kit

Sample type: Nasopharyngeal swab/ Throat swab / Sputum/Stool

Sensitivity: 300 copies/mL

Amplification time: 1h20min

Instrument: Four-channel RT-PCR instrument(FAM/JOE/ROX/CY5)

Storage & Shelf Life: -25℃~-15℃, 12 months

Performance：

Performance

Compared with the results of clinical diagnosis, the clinical sensitivity was 99.53%, and the clinical specificity was 97.92%.


​Donations：

Donations and sales

The nucleic acid detection kit donated by Fosun to the Portuguese central government this time has passed the emergency approval of the State Drug Administration and the EU CE certification, and obtained the medical device product registration certificate. At present, our nucleic acid detection kits have been exported to South Korea, Portugal, Hungary, Germany, Indonesia and other countries in the form of donations or sales.

China NMPA：
CE: Ref.：