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血脂测定试纸条(干化学法) - NMPA Registration 粤械注准20232401967

Access comprehensive regulatory information for 血脂测定试纸条(干化学法) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 粤械注准20232401967 and owned by Labnovation Technologies,inc.. The device was approved on November 27, 2023.

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.

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Class II
粤械注准20232401967
血脂测定试纸条(干化学法)
血脂测定试纸条(干化学法)
NMPA Registration Number: 粤械注准20232401967
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Intended Use
English

It is used to detect the content of cholesterol in human samples, and is mainly used in the auxiliary diagnosis of hypercholesterolemia in clinical practice. It is used to detect the content of high-density lipoprotein cholesterol in human samples, and is mainly used in the auxiliary diagnosis of hypercholesterolemia, coronary heart disease and atherosclerosis. It is used to detect the content of triglycerides in human samples, and is mainly used in the auxiliary diagnosis of hypertriglyceridemia in clinical practice.

中文

用于检测人体样本中胆固醇的含量,临床上主要用于高胆固醇血症的辅助诊断。用于检测人体样本中高密度脂蛋白胆固醇的含量,临床上主要用于高胆固醇血症、冠心病和动脉粥样硬化的辅助诊断。用于检测人体样本中甘油三酯的含量,临床上主要用于高甘油三酯血症的辅助诊断。

Device Classification
Device Class
Class II
Model Specifications
Aluminum foil bag single servings packing: 10 servings/box, 20 servings/box, 30 servings/box; Test strip packaging: 10 servings/tube.
铝箔袋单人份包装;规格:10人份/盒、20人份/盒、30人份/盒; 试纸筒包装;规格:10人份/筒。
Approval Department
Guangdong Provincial Drug Administration
广东省药品监督管理局
Registration Information
Registration Number
粤械注准20232401967
Approval Date
November 27, 2023
Expiry Date
November 26, 2028
Registrant
Name
Labnovation Technologies,inc.
深圳市雷诺华科技实业有限公司
Province/Region
Guangdong
广东
Address
102, 602, 702, 802, Shenghui Red Star Chuangzhi Plaza, Tongren Road, Tianliao Community, Yutang Street, Guangming District, Shenzhen
深圳市光明区玉塘街道田寮社区同仁路盛荟红星创智广场 102、602、 702、802
Production Facility
Production Address
广东省深圳市光明区玉塘街道田寮社区同仁路盛荟红星创智广场602、702、802
Structure and Composition
English

1. A single lipid test strip contains the following active ingredients Cholesterol lipase, glycerol kinase, cholesterol oxidase, 4-aminoantipyrine, oxygen-3-phosphateglycerol chemical enzymes, aniline derivatives, lipoprotein lipases, peroxidases. 2. Place one drying tablet in each individual package 3. 1 copy of the instruction manual

中文

1.单个血脂试纸条含有以下活性成分 胆固醇脂酶、甘油激酶、胆固醇氧化酶、4-氨基安替比林、3-磷酸甘油氧 化酶、苯胺衍生物、脂蛋白脂酶、过氧化物酶。 2.每个单独包装放置一个干燥片 3.说明书 1 份

Storage Conditions and Expiration
English

1. The sealed packaging of the test strip is stored at 2-30°C protected from light, it is forbidden to freeze, and the expiration date is 18 months. 2. The test strip is opened and then closed with the lid, and stored at 2-30°C under the condition of avoiding light and moisture, and the test strip is valid for 60 days. 3. Avoid heat and direct sunlight. 4. The test strip must be kept in its original packaging, please use the test strip immediately after it is removed. 5. Please refer to the product label or outer packaging box for details of the production date and expiration date.

中文

1. 密封包装的试纸条在 2-30℃避光保存,禁止冷冻,有效期为 18 个月。 2. 试纸筒开封随即盖上盖子,在 2-30℃避光防潮条件下保存,试纸筒开封试纸条有效期:60 天。 3. 避开热源和阳光直射。 4. 试纸条必须在原包装中保存,试纸条取出后请立即使用。 5. 生产日期及失效日期详见产品标签或外包装盒。

Additional Information
Appendix
产品技术要求、说明书