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胃泌素17测定试剂盒(直接化学发光法) - NMPA Registration 川械注准20242400303

Access comprehensive regulatory information for 胃泌素17测定试剂盒(直接化学发光法) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 川械注准20242400303 and owned by Maccura Biotechnology Co., Ltd.. The device was approved on November 19, 2024.

This page provides complete registration details including registrant information, province location (Sichuan), 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
川械注准20242400303
胃泌素17测定试剂盒(直接化学发光法)
胃泌素17测定试剂盒(直接化学发光法)
NMPA Registration Number: 川械注准20242400303
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Intended Use
English

本品用于体外定量测定人血清或血浆中胃泌素17的浓度.

中文

本品用于体外定量测定人血清或血浆中胃泌素17的浓度。

Device Classification
Device Class
Class II
Model Specifications
25测试/盒、 50测试/盒、 100测试/盒、 200测试/盒、 2×25测试/盒、 2×50测试/盒、 2×100测试/盒、 2×200测试/盒.
25测试/盒、 50测试/盒、 100测试/盒、 200测试/盒、 2×25测试/盒、 2×50测试/盒、 2×100测试/盒、 2×200测试/盒。
Approval Department
Sichuan Provincial Drug Administration
四川省药品监督管理局
Registration Information
Registration Number
川械注准20242400303
Approval Date
November 19, 2024
Expiry Date
November 18, 2029
Registrant
Name
Maccura Biotechnology Co., Ltd.
迈克生物股份有限公司
Province/Region
Sichuan
四川
Address
No. 16, Baichuan Road, Chengdu High-tech Zone
成都市高新区百川路16号
Production Facility
Production Address
成都市高新区百川路16号
Structure and Composition
English

试剂盒包含试剂1(R1):生物素标记的鼠抗胃泌素17单克隆抗体(2.0~6.0)μg/mL、磁微粒(0.2~0.6)mg/mL;试剂2(R2):吖啶酯标记的鼠抗胃泌素17单克隆抗体(0.1~0.4)μg/mL;试剂3(R3):磷酸盐缓冲液0.02mol/L;校准1(Cal1):胃泌素17抗原;校准2(Cal2):胃泌素17抗原.(具体内容详见产品说明书)

中文

试剂盒包含试剂1(R1):生物素标记的鼠抗胃泌素17单克隆抗体(2.0~6.0)μg/mL、磁微粒(0.2~0.6)mg/mL;试剂2(R2):吖啶酯标记的鼠抗胃泌素17单克隆抗体(0.1~0.4)μg/mL;试剂3(R3):磷酸盐缓冲液0.02mol/L;校准1(Cal1):胃泌素17抗原;校准2(Cal2):胃泌素17抗原。(具体内容详见产品说明书)

Storage Conditions and Expiration
English

This product is stored in 2 °C ~ 8 °C closed and protected from light, the expiration date is 18 months, and it is strictly forbidden to freeze.

中文

本品于2℃~8℃密闭避光保存,有效期为18个月,严禁冷冻。

Additional Information
Appendix
产品技术要求、说明书