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Lipid complex quality control - NMPA Registration 粤械注准20232401815

Access comprehensive regulatory information for Lipid complex quality control 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20232401815 and owned by Labnovation Technologies,inc.. The device was approved on November 06, 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20232401815
Lipid complex quality control
血脂复合质控品
NMPA Registration Number: 粤械注准20232401815
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Intended Use
English

It is used in conjunction with the blood lipid assay strip (dry chemical method) produced by Shenzhen Reynolds Technology Industry Co., Ltd. for indoor quality control of total cholesterol, high-density lipoprotein cholesterol and triglycerides.

中文

与深圳市雷诺华科技实业有限公司生产的血脂测定试纸条(干化学法)配套使用,用于总胆固醇、高密度脂蛋白胆固醇和甘油三酯的室内质量控制。

Device Classification
Device Class
Class II
Model Specifications
1mL×1
Approval Department
Guangdong Provincial Drug Administration
广东省药品监督管理局
Registration Information
Registration Number
粤械注准20232401815
Approval Date
November 06, 2023
Expiry Date
November 05, 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, 802, Shenghui Red Star Innovation Plaza, 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

The main components are BSA buffer, total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), and triglyceride (TG) high-value calibrators.

中文

主要成分为BSA缓冲液、总胆固醇(TC)、高密度脂蛋白胆固醇(HDL-C)、甘油三酯(TG)高值校准品。

Storage Conditions and Expiration
English

Store the controls in sealed packages at 2-8°C, tightly sealed and protected from light. Expiration date: The unopened control is stored under the specified storage conditions for an 18-month shelf life, and after opening, the storage period at 2-8°C is 30 days, please use before the expiration date indicated by the control.

中文

密封包装的质控品在2-8℃,密封避光储存。 有效期:未开瓶的质控品在指定贮存条件下贮存,有效期为18个月;开瓶后,储存与2-8℃的稳定期为30天,请在质控品表示的失效日期前使用。

Additional Information
Appendix
产品技术要求、说明书