Pure Global AI
China NMPA legacy archive 湘械注准20242401026

25-Hydroxyvitamin D Assay Kit (Fluorescence Immunochromatography)

25-羟基维生素D测定试剂盒(荧光免疫层析法)
Sinocare Inc.Class IINMPAApproved October 30, 2024
Static archiveNMPA · legacy registration snapshot
Device classification
Device class
Class II
Model specifications
10人份/盒、25人份/盒、50人份/盒、100人份/盒;质控品(选配,2 水平):冻干粉2*1mL,复溶液2*1mL.
10人份/盒、25人份/盒、50人份/盒、100人份/盒;质控品(选配,2 水平):冻干粉2*1mL,复溶液2*1mL。
Approval department
Hunan Provincial Drug Administration
湖南省药品监督管理局
Registration information
Registration number
湘械注准20242401026
Approval date
October 30, 2024
Expiry date
October 29, 2029
Registrant
Name
Sinocare Inc.
三诺生物传感股份有限公司
Province/Region
Hunan
湖南
Address
No. 265, Guyuan Road, Changsha High-tech Industrial Development Zone
长沙高新技术产业开发区谷苑路265号
Production facility
Production address
长沙高新技术产业开发区谷苑路265号
Intended use
English

用于体外定量测定人血清、血浆、静脉全血及末梢血中的25-羟基维生素D含量.

中文

用于体外定量测定人血清、血浆、静脉全血及末梢血中的25-羟基维生素D含量。

Structure and composition
English

试剂盒由测试卡、样本缓冲液、取样器(选配)、质控品(冻干粉,含复溶液,选配)和二维码(含校准曲线)组成.

中文

试剂盒由测试卡、样本缓冲液、取样器(选配)、质控品(冻干粉,含复溶液,选配)和二维码(含校准曲线)组成。

Storage conditions and expiration
English

原包装试剂在2℃～30℃条件下有效期为18个月,质控品2℃～8℃条件下存放的有效期为18个月;原包装试剂不可冷冻,测试卡铝箔袋开封后有效期为1小时,质控品复溶后2℃～8℃避光条件下可保存24h.

中文

原包装试剂在2℃～30℃条件下有效期为18个月，质控品2℃～8℃条件下存放的有效期为18个月；原包装试剂不可冷冻，测试卡铝箔袋开封后有效期为1小时，质控品复溶后2℃～8℃避光条件下可保存24h。

Additional information
Appendix
产品技术要求、说明书
About this record

This static archive preserves historical registration fields and translations for 25-Hydroxyvitamin D Assay Kit (Fluorescence Immunochromatography), registration 湘械注准20242401026. 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.