Free light chain κ assay kit (immunoturbidimetry method)
- Device class
- Class II
- Model specifications
- See annex for details
- Approval department
- Shanghai Municipal Drug Administration
- Registration number
- 沪械注准20232400360
- Approval date
- December 26, 2023
- Expiry date
- December 25, 2028
- Province/Region
- Shanghai
- Address
- 1189 Qinzhou North Road, Xuhui District, Shanghai
- Production address
- 上海市徐汇区钦州北路1189号
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。
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.