Nitric Oxide Assay Kit (Indirect Colorimetry) - NMPA Registration 皖械注准20232400190
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20232400190 and owned by Anhui Iprocom Biotechnology Co., Ltd.. The device was approved on October 19, 2023.
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.
This product is used for the quantitative determination of nitric oxide in human serum in vitro.
该产品用于体外定量测定人血清中一氧化氮的含量。
R1 Dopamine hydrochloride 100mmol/L Polyethylene glycol 8000 5g/L Acetic acid 50mmol/L Preservative: 5mL/L R2 3-Methyl-2-benzothiazolinone hydrazone hydrochloride hydrate (MBTH) 40mmol/L Glycine 50mmol/L Preservative: 5mL/L Polyethylene glycol 8000 5g/L Calibrator (optional) Sodium nitrite, sodium nitrate Controls level 1 and 2 (optional) sodium nitrite and sodium nitrate Concentrate: 1. The components in different batch number kits are not interchangeable; 2. The calibrators and quality controls are batch-specific, please refer to the target value list for details; 3. The product calibrator can be traced back to the working calibrator.
R1 盐酸多巴胺 100mmol/L 聚乙二醇 8000 5g/L 乙酸 50mmol/L 防腐剂 5mL/L R2 3-甲基-2-苯并噻唑啉酮腙盐酸盐水合物(MBTH) 40mmol/L 甘氨酸 50mmol/L 防腐剂 5mL/L 聚乙二醇 8000 5g/L 校准品（选配） 亚硝酸钠、硝酸钠 质控品水平一、二（选配）亚硝酸钠、硝酸钠 注： 1.不同批号试剂盒中各组分不可互换； 2.校准品、质控品具有批特异性，详情请见靶值单； 3.产品校准品溯源至工作校准品。
Unopened reagents, calibrators, and quality controls should be stored at 2°C~8°C in the dark, with an expiration date of 12 months, and no freezing; After opening the bottle, the reagent should be stored at 2°C~8°C in the dark, and the validity period is 30 days; After opening the bottle, the calibrators and quality control products should be stored at 2°C~8°C in the dark, pay attention to volatilization, and be valid for 30 days. Unopened reagents, calibrators, and quality controls should be stored at 2°C~8°C in the dark, with an expiration date of 12 months, and freezing is prohibited; After opening the bottle, the reagent should be stored at 2 °C ~ 8 °C in the dark, and the validity period is 30 days; After opening the bottle, the calibrator and quality control should be stored at 2°C~8°C in the dark, pay attention to volatilization, and be valid for 30 days.
未开封的试剂、校准品、质控品在 2℃～8℃避光保存，有效期12个月，禁止冷冻； 开瓶后试剂在 2℃～8℃避光保存，有效期30 天； 开瓶后的校准品、质控品在 2℃～8℃避光保存，注意挥发，有效期30天。 未开封的试剂、校准品、质控品在2℃～8℃避光保存，有效期12个月，禁止冷冻； 开瓶后试剂在2℃～8℃避光保存，有效期30天； 开瓶后的校准品、质控品在2℃～8℃避光保存，注意挥发，有效期30天。