Cytokeratin 19 fragment assay kit (chemiluminescence immunoassay analysis) - NMPA Registration 吉械注准20252400069

Access comprehensive regulatory information for Cytokeratin 19 fragment assay kit (chemiluminescence immunoassay analysis) 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20252400069 and owned by Dirui Industrial Co., Ltd.. The device was approved on January 24, 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20252400069

Cytokeratin 19 fragment assay kit (chemiluminescence immunoassay analysis)

细胞角蛋白19片段测定试剂盒(化学发光免疫分析法)

NMPA Registration Number: 吉械注准20252400069

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Intended Use

English

It is used for the quantitative detection of the content of cytokeratin 19 fragment (CYFRA21-1) in human serum or plasma in vitro, mainly used for dynamic monitoring of patients with malignant tumors to assist in judging the disease process or treatment effect, and cannot be used as the basis for early diagnosis or diagnosis of malignant tumors, and cannot be used for tumor screening in the general population.

中文

用于体外定量检测人血清或血浆中细胞角蛋白19片段（CYFRA21-1）的含量，主要用于对恶性肿瘤患者进行动态监测以辅助判断疾病进程或治疗效果，不能作为恶性肿瘤早期诊断或确诊的依据，不得用于普通人群的肿瘤筛查。

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20252400069

Approval Date

January 24, 2025

Expiry Date

February 06, 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：CYFRA21-1抗体包被的磁颗粒，试剂R2：吖啶酯标记的CYFRA21-1抗体，试剂R3: PBS缓冲溶液，校准品（高值、低值）：添加CYFRA21-1抗原的血清基质，质控品（水平1、水平2）：添加CYFRA21-1抗原的血清基质。（具体内容详见产品说明书）

Additional Information

Appendix

产品技术要求