Antimyeloperoxidase antibody IgG detection reagent kit (chemiluminescence method) - NMPA Registration 苏械注准20242402319
Access comprehensive regulatory information for Antimyeloperoxidase antibody IgG detection reagent kit (chemiluminescence 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 苏械注准20242402319 and owned by Nanjing Norman Biological Technology Co., Ltd.. The device was approved on December 13, 2024.
This page provides complete registration details including registrant information, province location (Jiangsu), 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.
用于体外定量检测人体血清、血浆中抗髓过氧化物酶抗体IgG(Anti-MPO IgG)的含量.
用于体外定量检测人体血清、血浆中抗髓过氧化物酶抗体IgG(Anti-MPO IgG)的含量。
A磁珠试剂:磁性微粒(≥0.1%),标记生物素的髓过氧化物酶(≥1μg/mL)(人),叠氮钠(0.3%),牛血清白蛋白(≥0.1%)(牛).B吖啶酯标记试剂:标记吖啶酯的抗人IgG(≥2μg/mL)(鼠),叠氮钠(0.3%),酪蛋白(≥0.25%)(牛).C辅助试剂:含酪蛋白(≥0.25%)(牛)和叠氮钠(0.3%)的Tris缓冲液(100mmol/L,pH=7.4).抗髓过氧化物酶抗体IgG质控品(选配):冻干粉,含抗髓过氧化物酶抗体IgG(鼠)的磷酸盐缓冲液基质(20mmol/L,pH=7.4).质控品水平1的浓度范围为7-13 AU/mL;水平2的浓度范围为35-65 AU/mL.抗髓过氧化物酶抗体IgG校准品(选配):冻干粉,含抗髓过氧化物酶抗体IgG(鼠)的磷酸盐缓冲液基质(20mmol/L,pH=7.4).校准品水平1的浓度范围为8-12 AU/mL;水平2的浓度范围为40-60 AU/mL.另外,还配有射频卡(含标准曲线用于产品定标).
A磁珠试剂：磁性微粒（≥0.1%），标记生物素的髓过氧化物酶（≥1μg/mL）（人），叠氮钠（0.3%），牛血清白蛋白（≥0.1%）（牛）。B吖啶酯标记试剂：标记吖啶酯的抗人IgG（≥2μg/mL）（鼠），叠氮钠（0.3%），酪蛋白（≥0.25%）（牛）。C辅助试剂：含酪蛋白（≥0.25%）（牛）和叠氮钠（0.3%）的Tris缓冲液（100mmol/L，pH=7.4）。抗髓过氧化物酶抗体IgG质控品（选配）：冻干粉，含抗髓过氧化物酶抗体IgG（鼠）的磷酸盐缓冲液基质（20mmol/L，pH=7.4）。质控品水平1的浓度范围为7-13 AU/mL；水平2的浓度范围为35-65 AU/mL。抗髓过氧化物酶抗体IgG校准品（选配）：冻干粉，含抗髓过氧化物酶抗体IgG（鼠）的磷酸盐缓冲液基质（20mmol/L，pH=7.4）。校准品水平1的浓度范围为8-12 AU/mL；水平2的浓度范围为40-60 AU/mL。另外，还配有射频卡（含标准曲线用于产品定标）。
Store stable at 2-8 °C for 15 months, avoid freezing. It is stable for 1 month after storage at 2-8 °C after opening. Controls and calibrators are stored in their original packaging at 2-8°C for 15 months. After reconstitution, the control and calibrator are stored at 2-8°C for 7 days.
2-8℃保存稳定15个月，避免冷冻。开瓶后2-8℃保存可稳定1个月。质控品和校准品2-8℃原包装储存有效期为15个月。复溶后，质控品和校准品2-8℃储存有效期均为7天。