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Nitric Oxide Assay Kit (Indirect Colorimetry) - NMPA Registration 皖械注准20222400121

Access comprehensive regulatory information for Nitric Oxide Assay Kit (Indirect Colorimetry) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 皖械注准20222400121 and owned by Anhui Daqian Bio-Engineering Limited Company. The device was approved on May 26, 2022.

This page provides complete registration details including registrant information, province location (Anhui), 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
皖械注准20222400121
Nitric Oxide Assay Kit (Indirect Colorimetry)
一氧化氮测定试剂盒(间接比色法)
NMPA Registration Number: 皖械注准20222400121
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Pricing
Intended Use
English

This product is used to indirectly determine nitric oxide (NO) concentration levels in human serum.

中文

本产品用于间接测定人体血清中一氧化氮(NO)浓度水平。

Device Classification
Device Class
Class II
Model Specifications
R1:1×15ml、R2:1×5ml;R1:4×60ml、R2:2×40ml;R1:2×40ml、R2:2×10ml;R1:1×30ml、R2:1×10ml; R1:4×60ml、R2:4×20ml; R1:2×60ml、R2:1×30ml; R1:1×45ml、R2:1×15ml; R1:4×30ml、R2:4×10ml; R1:2×60ml、R2:2×15ml; R1:1×60ml、R2:1×20ml; R1:1×40ml、R2:1×10ml; R1:2×80ml、R2:2×20ml; R1:2×30ml、R2:2×10ml; R1:1×60ml、R2:1×15ml; R1:4×60ml、R2:4×15ml; R1:2×45ml、R2:2×15ml; R1:1×80ml、R2:1×20ml; R1:4×60ml、R2:2×30ml; R1:2×60ml、R2:2×20ml; R1:1×20ml、R2:1×5ml; R1:4×40ml、R2:4×20ml; R1:1×60ml、R2:1×22ml; R1:1×60ml、R2:1×17ml; R1:2×60ml、R2:2×17ml; R1:2×60ml、R2:2×22ml; R1:12×60ml、R2:3×60ml;300测试;360测试;600测试;720测试.
R1:1×15ml、R2:1×5ml;R1:4×60ml、R2:2×40ml;R1:2×40ml、R2:2×10ml;R1:1×30ml、R2:1×10ml;R1:4×60ml、R2:4×20ml;R1:2×60ml、R2:1×30ml;R1:1×45ml、R2:1×15ml;R1:4×30ml、R2:4×10ml;R1:2×60ml、R2:2×15ml;R1:1×60ml、R2:1×20ml;R1:1×40ml、R2:1×10ml;R1:2×80ml、R2:2×20ml;R1:2×30ml、R2:2×10ml;R1:1×60ml、R2:1×15ml;R1:4×60ml、R2:4×15ml;R1:2×45ml、R2:2×15ml;R1:1×80ml、R2:1×20ml;R1:4×60ml、R2:2×30ml;R1:2×60ml、R2:2×20ml;R1:1×20ml、R2:1×5ml;R1:4×40ml、R2:4×20ml;R1:1×60ml、R2:1×22ml;R1:1×60ml、R2:1×17ml;R1:2×60ml、R2:2×17ml;R1:2×60ml、R2:2×22ml;R1:12×60ml、R2:3×60ml;300测试;360测试;600测试;720测试。
Approval Department
Anhui Provincial Drug Administration
安徽省药品监督管理局
Registration Information
Registration Number
皖械注准20222400121
Approval Date
May 26, 2022
Expiry Date
May 25, 2027
Registrant
Name
Anhui Daqian Bio-Engineering Limited Company
安徽大千生物工程有限公司
Province/Region
Anhui
安徽
Address
Anhui Province Hefei City Economic Development District Taohua Industrial Park prosperous Avenue Industrial Investment Liheng Industrial Plaza B12C
安徽省合肥市经开区桃花工业园繁华大道工投·立恒工业广场B12C
Production Facility
Production Address
安徽省合肥市经开区桃花工业园繁华大道工投·立恒工业广场B12C
Structure and Composition
English

Composition Composition: Concentration: Reagent 1 (R1), dopamine hydrochloride, 1.2mmol/L, Reagent, 2 (R2), 3-methyl-2-benzothiazolinone hydrazone hydrochloride, 14.8mmol/L, citric acid 100mmol/L

中文

组成 成分 浓度试剂 1(R1)盐酸多巴胺 1.2mmol/L试剂 2(R2)3-甲基-2-苯并噻唑啉酮腙盐酸盐14.8mmol/L柠檬酸 100mmol/L

Storage Conditions and Expiration
English

Reagent: 2°C~8°C storage in the dark can be stable for 18 months to prevent freezing. After opening, it can be stable for 30 days when stored at 2°C~8°C. Calibrators and quality controls: 2°C~8°C can be stable for 18 months when stored in the dark to prevent freezing. After opening, it can be stable for 7 days when stored at 2°C~8°C.

中文

试剂:2℃~8℃避光贮存可稳定 18 个月,防止冷冻。开瓶后于 2℃~8℃贮存可稳定 30 天。校准品、质控品:2℃~8℃避光贮存可稳定 18 个月,防止冷冻。开瓶后于 2℃~8℃贮存可稳定 7 天。