Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) - NMPA Registration 国械注准20243401443
Access comprehensive regulatory information for Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20243401443 and owned by Goldsite Diagnostics Inc.. The device was approved on August 09, 2024.
This page provides complete registration details including registrant information, province location (Guangdong), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.
This product is used for in vitro qualitative detection of novel coronavirus (2019-nCoV)N antigen in nasal swabs and nasopharyngeal swab samples of people with symptoms related to novel coronavirus infection, and other people who need to be diagnosed with new coronavirus infection. This product is mainly suitable for people in the early stage of infection, can not be used alone for the diagnosis of new coronavirus infection, positive antigen test is only used as the etiological evidence of new coronavirus infection, should be combined with epidemiological history, clinical manifestations, other laboratory tests, etc. for comprehensive analysis, diagnosis. A negative result does not rule out novel coronavirus infection. This product should not be used alone as a basis for making treatment and disease management decisions. The use of this product shall comply with the relevant requirements of the new coronavirus infection diagnosis and treatment plan and other documents. Novel coronavirus antigen testing should comply with the requirements of guidelines for new coronavirus sample collection and testing technology, and do a good job in biosecurity.
本产品用于体外定性检测具有新型冠状病毒感染相关症状人群、其他需要进行新型冠状病毒感染诊断人群鼻拭子和鼻咽拭子样本中新型冠状病毒（2019-nCoV）N抗原。本产品主要适用于感染早期人群，不能单独用于新型冠状病毒感染的诊断，抗原检测阳性仅作为新型冠状病毒感染的病原学证据，应结合流行病学史、临床表现、其他实验室检查等进行综合分析，做出诊断。阴性结果不能排除新型冠状病毒感染。本产品不得单独作为作出治疗和疾病管理决定的依据。该产品在使用上应当遵守新型冠状病毒感染诊疗方案等文件的相关要求。开展新型冠状病毒抗原检测，应符合新冠病毒样本采集和检测技术相关指南的要求，做好生物安全工作。
The kit consists of a test card, an extraction tube containing the sample processing solution, and a sealed bag. (Please refer to the product manual for details)
试剂盒由测试卡、提取管（内含样本处理液）和密封袋组成。（具体内容详见产品说明书）
The test card is stored at 2°C~30°C and is valid for 18 months. The sample processing solution was stored at 2°C~30°C and had an expiration date of 18 months.
测试卡2℃～30℃保存，有效期18个月。样本处理液2℃～30℃保存，有效期18个月。