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κ游离轻链检测试剂盒(散射比浊法) - NMPA Registration 渝械注准20242400439

Access comprehensive regulatory information for κ游离轻链检测试剂盒(散射比浊法) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 渝械注准20242400439 and owned by Chongqing Biostec Biological Technology Co., Ltd.. The device was approved on October 29, 2024.

This page provides complete registration details including registrant information, province location (Chongqing), 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
渝械注准20242400439
κ游离轻链检测试剂盒(散射比浊法)
κ游离轻链检测试剂盒（散射比浊法）
NMPA Registration Number: 渝械注准20242400439
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Intended Use
English

用于体外定量检测人体样本(血清)中的κ游离轻链(F-Kappa).

中文

用于体外定量检测人体样本（血清）中的κ游离轻链（F-Kappa）。

Device Classification
Device Class
Class II
Model Specifications
稀释缓冲液:15mL×1,抗体-胶乳溶液:5mL×1; 稀释缓冲液:25mL×1,抗体-胶乳溶液:9mL×1; 稀释缓冲液:25mL×2,抗体-胶乳溶液:9mL×2; 稀释缓冲液:25mL×2,抗体-胶乳溶液:17mL×1; 稀释缓冲液:30mL×1,抗体-胶乳溶液:10mL×1; 稀释缓冲液:36mL×1,抗体-胶乳溶液:12mL×1; 稀释缓冲液:30mL×2,抗体-胶乳溶液:20mL×1; 稀释缓冲液:60mL×1,抗体-胶乳溶液:20mL×1; 稀释缓冲液:60mL×2,抗体-胶乳溶液:20mL×2; 稀释缓冲液:750mL×1,抗体-胶乳溶液:250mL×1; 稀释缓冲液:3000mL×1,抗体-胶乳溶液:1000mL×1; 20T/盒;50T/盒;100T/盒;200T/盒;400T/盒;1000T/盒. κ游离轻链校准品(选配)(4水平):4水平×1×0.3mL、4水平×1×0.5mL、4水平×1×1mL. κ游离轻链质控品(选配)(2水平):2水平×1×0.5mL、2水平×1×1mL.
稀释缓冲液：15mL×1，抗体-胶乳溶液：5mL×1； 稀释缓冲液：25mL×1，抗体-胶乳溶液：9mL×1； 稀释缓冲液：25mL×2，抗体-胶乳溶液：9mL×2； 稀释缓冲液：25mL×2，抗体-胶乳溶液：17mL×1； 稀释缓冲液：30mL×1，抗体-胶乳溶液：10mL×1； 稀释缓冲液：36mL×1，抗体-胶乳溶液：12mL×1； 稀释缓冲液：30mL×2，抗体-胶乳溶液：20mL×1； 稀释缓冲液：60mL×1，抗体-胶乳溶液：20mL×1； 稀释缓冲液：60mL×2，抗体-胶乳溶液：20mL×2； 稀释缓冲液：750mL×1，抗体-胶乳溶液：250mL×1； 稀释缓冲液：3000mL×1，抗体-胶乳溶液：1000mL×1； 20T/盒；50T/盒；100T/盒；200T/盒；400T/盒；1000T/盒。 κ游离轻链校准品（选配）（4水平）：4水平×1×0.3mL、4水平×1×0.5mL、4水平×1×1mL。 κ游离轻链质控品（选配）（2水平）：2水平×1×0.5mL、2水平×1×1mL。
Approval Department
Chongqing Municipal Drug Administration
重庆市药品监督管理局
Registration Information
Registration Number
渝械注准20242400439
Approval Date
October 29, 2024
Expiry Date
October 28, 2029
Registrant
Name
Chongqing Biostec Biological Technology Co., Ltd.
重庆博士泰生物技术有限公司
Province/Region
Chongqing
重庆
Address
1st and 2nd floor, Building 2, No. 17, Camellia Road, Changshengqiao Town, Nan'an District, Chongqing
重庆市南岸区长生桥镇茶花路17号2幢1、2楼
Production Facility
Production Address
重庆市南岸区茶花路17号2幢1楼、2楼、3楼2-1、2-2
Structure and Composition
English

由稀释缓冲液、抗体-胶乳溶液、κ游离轻链校准品(选配)和κ游离轻链质控品(选配)组成.(具体内容详见产品说明书)

中文

由稀释缓冲液、抗体-胶乳溶液、κ游离轻链校准品（选配）和κ游离轻链质控品（选配）组成。(具体内容详见产品说明书)

Storage Conditions and Expiration
English

本品在2～8℃密闭保存可稳定12个月,试剂开瓶后在2～8℃条件下保存并应在14天内使用,校准品、质控品开瓶后在2～8℃条件下可保存7天.

中文

本品在2～8℃密闭保存可稳定12个月，试剂开瓶后在2～8℃条件下保存并应在14天内使用，校准品、质控品开瓶后在2～8℃条件下可保存7天。

Additional Information
Remark
首次注册。