Catecholamines and their metabolite controls - NMPA Registration 京械注准20232400015

Access comprehensive regulatory information for Catecholamines and their metabolite controls in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 京械注准20232400015 and owned by Beijing BGI-GBI Biotech Co., Ltd.. The device was approved on January 04, 2023.

This page provides complete registration details including registrant information, province location (Beijing), 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

京械注准20232400015

Catecholamines and their metabolite controls

儿茶酚胺及其代谢物质控品

NMPA Registration Number: 京械注准20232400015

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Intended Use

English

It is used in conjunction with the sample release agent (catecholamine-magnetic bead method) and applicable instruments produced by the company for indoor quality control of six indicators, including methoxyepinephrine (MN), methoxynorepinephrine (NMN), 3-methoxytyramine (3-MT), epinephrine (E), norepinephrine (NE), and dopamine (DA).

中文

与本公司生产的样本释放剂（儿茶酚胺-磁珠法）及适用仪器配套使用，用于甲氧基肾上腺素（MN）、甲氧基去甲肾上腺素（NMN）、3-甲氧基酪胺（3-MT）、肾上腺素（E）、去甲肾上腺素（NE）、多巴胺（DA）共6项指标的室内质量控制。

Device Classification

Device Class

Class II

Model Specifications

1.1 Packaging specifications Low-value controls: 1×1.5mL (dry powder, reconstituted volume), high-value controls: 1×1.5mL (dry powder, reconstituted volume); Low-value controls: 2×1.5mL (dry powder, reconstituted volume), high-value controls: 2×1.5mL (dry powder, reconstituted volume).

1.1包装规格低值质控品：1×1.5mL (干粉，复溶体积)，高值质控品：1×1.5mL (干粉，复溶体积)；低值质控品：2×1.5mL (干粉，复溶体积)，高值质控品：2×1.5mL (干粉，复溶体积)。

Approval Department

Beijing Municipal Drug Administration

北京市药品监督管理局

Registration Information

Registration Number

京械注准20232400015

Approval Date

January 04, 2023

Expiry Date

January 03, 2028

Registrant

Name

Beijing BGI-GBI Biotech Co., Ltd.

北京华大吉比爱生物技术有限公司

Province/Region

Beijing

北京

Address

Room 236, Room 237, Building 1, No. 538, Yongfeng Tun, Haidian District, Beijing

北京市海淀区永丰屯538号1号楼236、237室

Production Facility

Production Address

北京市顺义区临空经济核心区裕华路28号6号4层，8号2层西侧，12号3层西，12号1层西侧

Structure and Composition

English

Note: The quality control is batch specific, and the specific concentration is shown in the target value list.

中文

备注：质控品具有批特异性，具体浓度见靶值单。

Storage Conditions and Expiration

English

Avoid unopened kits below -18 °C

中文

未开封试剂盒在-18℃以下避

Additional Information

Appendix

产品技术要求、说明书