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China NMPA legacy archive 沪械注准20232400360

Free light chain κ assay kit (immunoturbidimetry method)

轻链κ测定试剂盒(免疫比浊法)
Shanghai Kehua Bio-Engineering Co., Ltd.Class IINMPAApproved December 26, 2023
Static archiveNMPA · legacy registration snapshot
Device classification
Device class
Class II
Model specifications
See annex for details
详见附件
Approval department
Shanghai Municipal Drug Administration
上海市药品监督管理局
Registration information
Registration number
沪械注准20232400360
Approval date
December 26, 2023
Expiry date
December 25, 2028
Registrant
Name
Shanghai Kehua Bio-Engineering Co., Ltd.
上海科华生物工程股份有限公司
Province/Region
Shanghai
上海
Address
1189 Qinzhou North Road, Xuhui District, Shanghai
上海市徐汇区钦州北路1189号
Production facility
Production address
上海市徐汇区钦州北路1189号
Intended use
English

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.

中文

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。

Structure and composition
English

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.

中文

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。

Storage conditions and expiration
English

Store at 2~8°C away from light, and the expiration date is 9 months.

中文

2~8℃避光保存,有效期为9个月。

About this record

This static archive preserves historical registration fields and translations for Free light chain κ assay kit (immunoturbidimetry method), registration 沪械注准20232400360. It does not establish current authorization or complete current product details.

The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.