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Total Iron Binding Capacity Test Kit (Ferene Method) - NMPA Registration 滇械注准20162400127

Access comprehensive regulatory information for Total Iron Binding Capacity Test Kit (Ferene Method) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 滇械注准20162400127 and owned by Yunnan Haoxu Biotechnology Co., Ltd.. The device was approved on September 23, 2021.

This page provides complete registration details including registrant information, province location (Yunnan), 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
滇械注准20162400127
Total Iron Binding Capacity Test Kit (Ferene Method)
总铁结合力检测试剂盒(Ferene法)
NMPA Registration Number: 滇械注准20162400127
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Intended Use
English

It is used to detect the total iron binding capacity of human serum, and is mainly used clinically for the auxiliary diagnosis of anemia.

中文

用于检测人血清的总铁结合力,临床上主要用于贫血的辅助诊断。

Device Classification
Device Class
Class II
Model Specifications
Fe reagents: R1: 25mL× 1 R2: 5mL×1 UIBC reagents: R1: 25mL× 1 R2: 5mL×1 Fe reagents: R1: 40mL× 1 R2: 8mL×1 UIBC reagents: R1: 40mL× 1 R2: 8mL×1 Fe reagents: R1: 40mL× 2 R2: 8mL×2 UIBC reagents: R1: 40mL×2 R2: 8mL×2 50 test×1 100 test×1 200 test×1 1L×1 Calibrator: 1mL (optional) Control: 1mL (optional)
Fe试剂:R1:25mL×1 R2:5mL×1 UIBC试剂:R1:25mL×1 R2:5mL×1 Fe试剂:R1:40mL×1 R2:8mL×1 UIBC试剂:R1:40mL×1 R2:8mL×1 Fe试剂:R1:40mL×2 R2:8mL×2 UIBC试剂:R1:40mL×2 R2:8mL×2 50 test×1 100 test×1 200 test×1 1L×1 校准品:1mL(可选购) 质控品:1mL(可选购)
Approval Department
Yunnan Provincial Drug Administration
云南省药品监督管理局
Registration Information
Registration Number
滇械注准20162400127
Approval Date
September 23, 2021
Expiry Date
September 22, 2026
Registrant
Name
Yunnan Haoxu Biotechnology Co., Ltd.
云南昊戌生物科技有限公司
Province/Region
Yunnan
云南
Address
Production workshop on the 3rd floor of No. 4 Industrial Standard Workshop of Block A6-2, High-tech Industrial Base, Majinpu Township, High-tech Industrial Base, Kunming City, Yunnan Province
云南省昆明市高新区马金铺乡新城高新技术产业基地A6-2地块4号工业标准厂房3层生产车间
Production Facility
Production Address
云南省昆明市高新区马金铺乡新城高新技术产业基地A6-2地块4号工业标准厂房3层生产车间
Structure and Composition
English

Fe reagent: R1: citric acid buffer PH4.5 250mmol/L, thiourea 42 mmol/L R2: Ferene 1 mmol/L UIBC reagents: R1: Tris buffer PH8.6 0.3 M, thiourea 42 mmol/L R2: Ferene 1 mmol/L, ascorbic acid 75 mmol/L

中文

Fe试剂:R1:柠檬酸缓冲液PH4.5 250mmol/L、硫脲 42 mmol/L R2:Ferene 1 mmol/L UIBC试剂:R1:Tris缓冲液PH8.6 0.3M、硫脲 42 mmol/L R2: Ferene 1 mmol/L、抗坏血酸 75 mmol/L

Storage Conditions and Expiration
English

The kit is stored at 2~8 °C and can be stable for one year in the dark. After opening the reagent, pay attention to avoid contamination, 2~8 °C can be stable for one week, it is recommended to use it up as soon as possible.

中文

试剂盒贮存在2~8℃下,避光保存可稳定一年。 试剂开瓶后注意避免污染,2~8℃可稳定一周,建议尽快用完。