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Free triiodothyronine assay kit (electrochemiluminescence) - NMPA Registration 浙械注准20242401776

Access comprehensive regulatory information for Free triiodothyronine assay kit (electrochemiluminescence) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 浙械注准20242401776 and owned by Ningbo Ruiyuan Biotechnology Co., Ltd.. The device was approved on September 19, 2024.

This page provides complete registration details including registrant information, province location (Zhejiang), 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
浙械注准20242401776
Free triiodothyronine assay kit (electrochemiluminescence)
游离三碘甲状腺原氨酸测定试剂盒(电化学发光法)
NMPA Registration Number: 浙械注准20242401776
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Intended Use
English

This kit is used for the quantitative determination of free triiodothyronine concentration in human serum and plasma in vitro.

中文

本试剂盒用于体外定量测定人血清和血浆中游离三碘甲状腺原氨酸的浓度。

Device Classification
Device Class
Class II
Model Specifications
200 tests/box; 2×200 tests/box; 3×200 tests/box; 4×200 tests/box; 300 tests/box; 2×300 tests/box; 3×300 tests/box; 4×300 tests/box.
200测试/盒;2×200测试/盒;3×200测试/盒;4×200测试/盒; 300测试/盒;2×300测试/盒;3×300测试/盒;4×300测试/盒。
Approval Department
Zhejiang Provincial Drug Administration
浙江省药品监督管理局
Registration Information
Registration Number
浙械注准20242401776
Approval Date
September 19, 2024
Expiry Date
September 18, 2029
Registrant
Name
Ningbo Ruiyuan Biotechnology Co., Ltd.
宁波瑞源生物科技有限公司
Province/Region
Zhejiang
浙江
Address
No. 288, Huangjipu Road, Jiangbei District, Ningbo City
宁波市江北区皇吉浦路288号
Production Facility
Production Address
宁波市江北区皇吉浦路288号
Structure and Composition
English

Solid phase reagents, ruthenium labeling reagents, biotinylation reagents, calibrators (Cal1, Cal2), quality controls (L, H). (Please refer to the manual for details)

中文

固相试剂、钌标记试剂、生物素化试剂、校准品(Cal1、Cal2)、质控品(L、H)。(具体内容详见说明书)

Storage Conditions and Expiration
English

The reagent can be stored upright at 2~8°C and can be stable for 12 months. The calibrators and quality controls are stored at 2~8°C, and can be stable for 12 months when stored in the dark.

中文

试剂在2~8℃避光条件下直立保存,可稳定12个月。校准品和质控品贮存于2~8℃,避光保存可稳定12个月。

Additional Information
Appendix
产品技术要求、说明书