Free light chain κ assay kit (immunoturbidimetry method) - NMPA Registration 沪械注准20232400360
Access comprehensive regulatory information for Free light chain κ assay kit (immunoturbidimetry method) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 沪械注准20232400360 and owned by Shanghai Kehua Bio-Engineering Co., Ltd.. The device was approved on December 26, 2023.
This page provides complete registration details including registrant information, province location (Shanghai), 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 kit is used by medical institutions for in vitro quantitative determination of light chain κ (Kappa) concentration in human serum and plasma samples for auxiliary diagnosis.
本试剂盒供医疗机构用于体外定量测定人血清、血浆样本中轻链κ（Kappa）浓度，作辅助诊断用。
Reagent 1 (R1): Good's buffer, Reagent 2 (R2): Good's buffer, sheep anti-human light chain kappa antibody, calibrator a-e: Good's buffer, human light chain kappa antigen, control L, H: Good's buffer, human light chain kappa antigen.
试剂1（R1）：Good’s缓冲液；试剂2（R2）：Good’s缓冲液、羊抗人轻链κ抗体；校准品a-e：Good’s缓冲液、人源轻链κ抗原；质控品L、H：Good’s缓冲液、人源轻链κ抗原。
Store at 2~8°C away from light, and the expiration date is 9 months.
2~8℃避光保存，有效期为9个月。