Alpha-fetoprotein (AFP) determination reagent kit (chemiluminescence immunoassay) - NMPA Registration 国械注准20233400094

Access comprehensive regulatory information for Alpha-fetoprotein (AFP) determination reagent kit (chemiluminescence immunoassay) in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20233400094 and owned by Rayto Life and Analytical Sciences Co., Ltd.. The device was approved on January 30, 2023.

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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NMPA Official Data

Class III

国械注准20233400094

Alpha-fetoprotein (AFP) determination reagent kit (chemiluminescence immunoassay)

甲胎蛋白（AFP）测定试剂盒（化学发光免疫分析法）

NMPA Registration Number: 国械注准20233400094

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Intended Use

English

This product is used for the quantitative detection of alpha-fetoprotein (AFP) content 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, can not be used as the basis for early diagnosis or diagnosis of malignant tumors, can not be used for tumor screening in the general population.

中文

本产品用于体外定量检测人血清或血浆中甲胎蛋白（AFP）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，不能用于普通人群的肿瘤筛查。

Device Classification

Device Class

Class III

Model Specifications

30 tests/box, 50 tests/box, 100 tests/box, 200 tests/box, 30 tests/box (C), 50 tests/box (C), 100 tests/box (C), 200 tests/box (C), 30 tests/box (Q), 50 tests/box (Q), 100 tests/box (Q), 200 tests/box (Q), 30 tests/box (CQ), 50 tests/box (CQ), 100 tests/box (CQ), 200 tests/box (CQ).

30测试/盒、50测试/盒、100测试/盒、200测试/盒，30测试/盒(C)、 50测试/盒(C)、100测试/盒(C)、200测试/盒(C)，30测试/盒(Q)、50测试/盒(Q)、100测试/盒(Q)、200测试/盒(Q)，30测试/盒(CQ)、50测试/盒(CQ)、100测试/盒(CQ)、200测试/盒(CQ)。

Approval Department

State Drug Administration

国家药品监督管理局

Registration Information

Registration Number

国械注准20233400094

Approval Date

January 30, 2023

Expiry Date

January 29, 2028

Registrant

Name

Rayto Life and Analytical Sciences Co., Ltd.

深圳雷杜生命科学股份有限公司

Province/Region

Guangdong

广东

Address

The second floor of Building 5, Software Park, No. 2, Gaoxin Zhongsan Road, Yuehai Street, Nanshan District, Shenzhen

深圳市南山区粤海街道高新中三道二号软件园五号楼二层

Production Facility

Production Address

深圳市光明新区高新东片区双明大道南侧雷杜工业大厦

Structure and Composition

English

The kit consists of immunomagnetic beads (M), enzyme conjugates (R), calibrator 1, calibrator 2, control 1, and control 2. (Please refer to the product manual for details)

中文

试剂盒由免疫磁珠（M）、酶结合物（R）、校准品1、校准品2、质控品1、质控品2组成。（具体内容详见产品说明书）

Storage Conditions and Expiration

English

This product is stored at 2 °C ~ 8 °C and is valid for 12 months.

中文

本产品在2℃～8℃保存，有效期为12个月。

Additional Information

Appendix

产品技术要求、说明书