Angiotensin II assay kit (chemiluminescence immunoassay) - NMPA Registration 吉械注准20252400060

Access comprehensive regulatory information for Angiotensin II assay kit (chemiluminescence immunoassay) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 吉械注准20252400060 and owned by Dirui Industrial Co., Ltd.. The device was approved on January 21, 2025.

This page provides complete registration details including registrant information, province location (Jilin), 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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NMPA Official Data

Class II

吉械注准20252400060

Angiotensin II assay kit (chemiluminescence immunoassay)

血管紧张素Ⅱ测定试剂盒(化学发光免疫分析法)

NMPA Registration Number: 吉械注准20252400060

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Intended Use

English

用于体外定量检测人血浆中血管紧张素Ⅱ的含量。

Device Classification

Device Class

Class II

Model Specifications

1×50 test/box; 1×50 test/box (excluding calibrators and quality controls); 2×50 tests/box; 2×50 test/box (excluding calibrators and quality controls); 1×100 tests/box; 1×100 tests/box (excluding calibrators and quality controls); 2×100 tests/box; 2×100 tests/box (excluding calibrators and quality controls); 4×100 tests/box; 4×100 tests/box (excluding calibrators and quality controls); 1×200 tests/box; 1×200 tests/box (excluding calibrators and quality controls); 2×200 tests/box; 2×200 tests/box (excluding calibrators and quality controls).

1×50测试/盒；1×50测试/盒（不含校准品、质控品）； 2×50测试/盒；2×50测试/盒（不含校准品、质控品）； 1×100测试/盒；1×100测试/盒（不含校准品、质控品）； 2×100测试/盒；2×100测试/盒（不含校准品、质控品）； 4×100测试/盒；4×100测试/盒（不含校准品、质控品）； 1×200测试/盒；1×200测试/盒（不含校准品、质控品）； 2×200测试/盒；2×200测试/盒（不含校准品、质控品）。

Approval Department

Jilin Provincial Drug Administration

吉林省药品监督管理局

Registration Information

Registration Number

吉械注准20252400060

Approval Date

January 21, 2025

Expiry Date

January 20, 2030

Registrant

Name

Dirui Industrial Co., Ltd.

迪瑞医疗科技股份有限公司

Province/Region

Jilin

吉林

Address

No. 95, Yunhe Street, Changchun High-tech Industrial Development Zone

长春市高新技术产业开发区云河街95号

Production Facility

Production Address

长春市高新技术产业开发区云河街95号

Structure and Composition

English

试剂R1：链霉亲和素磁颗粒 ≥0.03%，三（羟甲基）氨基甲烷缓冲液 10～100mmol/L，叠氮化钠 ≤0.1%，ProClin 300 ≤0.2%；试剂R2：吖啶酯标记的血管紧张素Ⅱ鼠单抗 ≥10ng/mL，1,3-二 [三（羟甲基）] 甲氨基丙烷缓冲液 50～400mmol/L，ProClin 300 ≤0.2%；试剂R3：生物素标记的血管紧张素Ⅱ衍生物 ≥3ng/mL，1,3-二 [三（羟甲基）] 甲氨基丙烷缓冲液 50～400mmol/L，ProClin 300 ≤0.2%；校准品（高值、低值）：添加血管紧张素Ⅱ的蛋白组分含量见标签，磷酸盐缓冲液10～100mmol/L，叠氮化钠 ≤0.1%，ProClin 300 ≤0.2%；质控品（水平1、水平2）：添加血管紧张素Ⅱ的蛋白组分含量见标签，磷酸盐缓冲液 10～100mmol/L，叠氮化钠 ≤0.1%，ProClin 300 ≤0.2%；

Additional Information

Appendix

产品技术要求