Adenosine deaminase assay kit (peroxidase method) - NMPA Registration 皖械注准20242400111
Access comprehensive regulatory information for Adenosine deaminase assay kit (peroxidase 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 皖械注准20242400111 and owned by Anhui Iprocom Biotechnology Co., Ltd.. The device was approved on August 04, 2024.
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 in vitro to quantify the activity of adenosine deaminase in human serum or plasma.
该产品用于体外定量测定人血清或血浆中腺苷脱氨酶的活性。
R1:Tris缓冲液 50mmol/L、4-氨基安替比林 0.4g/L、黄嘌呤氧化酶 2KU/L、嘌呤核苷磷酸化酶 0.5KU/L、过氧化物酶 1.5KU/L R2:腺苷 2.5g/L、N-乙基-N-(2-羟基-3-磺丙基)-3-甲基苯胺钠盐 0.3g/L; 校准品(选配):Tris缓冲液、腺苷脱氨酶(ADA)目标浓度:80U/L; 质控品水平一、二(选配):Tris缓冲液、腺苷脱氨酶(ADA)水平一目标浓度:38U/L,水平二目标浓度:110U/L.
R1:Tris缓冲液 50mmol/L、4-氨基安替比林 0.4g/L、黄嘌呤氧化酶 2KU/L、嘌呤核苷磷酸化酶 0.5KU/L、过氧化物酶 1.5KU/L R2:腺苷 2.5g/L、N-乙基-N-(2-羟基-3-磺丙基)-3-甲基苯胺钠盐 0.3g/L； 校准品（选配）：Tris缓冲液、腺苷脱氨酶（ADA）目标浓度：80U/L； 质控品水平一、二（选配）：Tris缓冲液、腺苷脱氨酶（ADA）水平一目标浓度：38U/L，水平二目标浓度：110U/L。
Unopened reagents, calibrators, and quality controls should be stored at 2°C ~ 8°C in the dark, with an expiration date of 18 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 28 days; The reconstituted calibrator is stored at 2°C ~ 8°C in the dark, pay attention to volatilization, and the validity period is 24 hours; The reconstituted calibrator was frozen at -20°C (±2°C), with attention to volatilization, and was valid for 7 days; The reconstituted quality control is stored at 2°C ~ 8°C in the dark, pay attention to volatilization, and the expiration date is 24 hours; The reconstituted quality control was frozen at -20°C (±2°C), with attention to volatilization, and the expiration date was 7 days.
未开封的试剂、校准品、质控品在2℃ ~ 8℃避光保存，有效期18个月，禁止冷冻； 开瓶后试剂在2℃ ~ 8℃避光保存，有效期28天； 复溶后的校准品2℃ ~ 8℃避光保存，注意挥发，有效期24小时；复溶后的校准品 -20℃（±2℃）冷冻保存，注意挥发，有效期7天； 复溶后的质控品2℃ ~ 8℃避光保存，注意挥发，有效期24小时；复溶后的质控品 -20℃（±2℃）冷冻保存，注意挥发，有效期7天。