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Electrolyte (Na—K—Cl) controls - NMPA Registration 粤械注准20232401966

Access comprehensive regulatory information for Electrolyte (Na—K—Cl) controls 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20232401966 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20232401966
Electrolyte (Na—K—Cl) controls
电解质(Na—K—Cl)质控品
NMPA Registration Number: 粤械注准20232401966
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Intended Use
English

For systematic quality control of dry chemistry analyzers when testing items using electrolyte (Na-K-Cl) assay kits.

中文

用于干式生化分析仪使用电解质(Na-K-Cl)测定试剂盒检测项目时系统的质量控制。

Device Classification
Device Class
Class II
Model Specifications
Level 1: 2×1mL Level 2:2×1mL Level 3: 2×1mL
水平 1:2×1mL 水平 2:2×1mL 水平 3:2×1mL
Approval Department
Guangdong Provincial Drug Administration
广东省药品监督管理局
Registration Information
Registration Number
粤械注准20232401966
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

The main ingredients are potassium dihydrogen phosphate, sodium chloride, sodium dihydrogen phosphate, and preservative (Proclin 300).

中文

主要成分为磷酸二氢钾、氯化钠、磷酸二氢钠、防腐剂(Proclin 300)。

Storage Conditions and Expiration
English

1. When unopened, store at 2~8°C, and the expiration date is 18 months. In unopened condition, it can be stabilized to the date shown on the package. 2. The unused solution should be sealed and stored at 2~8°C after opening, and the solution should be stopped 30 days after opening. The date of manufacture and the expiration date are shown on the outer box label.

中文

1.未开封时,在 2~8℃条件下储存,有效期为 18 个月。在未打开包装的条件下,可以稳定到包装上所示日期。 2.开封后未使用完的溶液应于 2~8℃条件下密封储存,溶液应在开封 30 天后停止使用。 生产日期及使用期限见外包装盒标签。

Additional Information
Appendix
产品技术要求、说明书