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高敏肌钙蛋白Ⅰ(hs-cTnI)测定试剂盒(化学发光免疫分析法) - NMPA Registration 粤械注准20252400021

Access comprehensive regulatory information for 高敏肌钙蛋白Ⅰ(hs-cTnI)测定试剂盒(化学发光免疫分析法) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 粤械注准20252400021 and owned by Guangzhou Yichuan Biotechnology Co., Ltd.. The device was approved on January 06, 2025.

This page provides complete registration details including registrant information, province location (Guangdong), 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
粤械注准20252400021
高敏肌钙蛋白Ⅰ(hs-cTnI)测定试剂盒(化学发光免疫分析法)
NMPA Registration Number: 粤械注准20252400021
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Pricing
Intended Use
English

用于体外定量测定人血清或血浆样本中心肌肌钙蛋白Ⅰ的含量。临床上主要用于心肌梗死的辅助诊断。

Device Classification
Device Class
Class II
Model Specifications
试剂盒:50人份/盒、100人份/盒、200人份/盒。校准品(选配):冻干型 1mL×3;质控品(选配):冻干型 1mL×2。
Approval Department
Guangdong Provincial Drug Administration
广东省药品监督管理局
Registration Information
Registration Number
粤械注准20252400021
Approval Date
January 06, 2025
Expiry Date
January 05, 2030
Registrant
Name
Guangzhou Yichuan Biotechnology Co., Ltd.
广州市伊川生物科技有限公司
Province/Region
Guangdong
广东
Address
Room 601, Building E, No. 188 Kaiyuan Avenue, Huangpu District, Guangzhou, Room 601, Building F
广州市黄埔区开源大道188号E栋601房F栋601房
Production Facility
Production Address
广州市黄埔区开源大道188号E栋601房F栋601房
Structure and Composition
English

R1(磁珠工作液):包被着cTnI抗体(鼠单抗)的超顺磁性微粒; R2(吖啶酯工作液):cTnI抗体(鼠单抗)-吖啶酯标记物。 校准品(选配):校准品水平 A为抗原稀释液(氯化钠),校准品水平B、C为含有不同浓度cTnI的抗原稀释液(重组,E.coli)。 质控品(选配):质控品水平 1、2 为含有不同浓度cTnI的抗原稀释液(重组,E.coli)。

Storage Conditions and Expiration
English

试剂在2℃~8℃保存,自生产之日起有效期为12个月;试剂开瓶后于2℃~8℃在机储存28天;2℃~8℃冰箱储存,可稳定28天;校准品/质控品在2℃~8℃保存,自生产之日起有效期为12个月;校准品或质控品使用前用1.0mL 纯化水复溶,复溶后-20℃±5℃保存,可稳定30天,冻融不超过1次,开瓶后常温(10℃~30℃)可稳定1小时。试剂在使用或储存过程中必须包装竖直向上放置;生产日期见包装盒。

Additional Information
Appendix
产品技术要求、说明书