Anti-streptolysin O (ASO) Assay Kit (Timed Scatter Turbidimetry)
- Device class
- Class II
- Model specifications
- PA480/PA480A/PA480C/PA480S; Packing specifications for PA240/PA240A/PA240C/PA240S: 25 servings/box, 50 servings/box, 100 servings/box, 150 servings/box, 200 servings/box, 250 servings/box, 300 servings/box, QC 1 (optional), QC 2 (optional), QC 3 (optional), calibrator 1 (optional), calibrator 2 (optional), calibrator 3 (optional), calibrator 4 (optional), calibrator 5 (optional), calibrator 6 (optional); Packaging specifications for PA120: 50 servings/box, 100 servings/box, 150 servings/box, 200 servings/box, QC 1 (optional), QC 2 (optional), QC 3 (optional), calibrator 1 (optional), calibrator 2 (optional), calibrator 3 (optional), calibrator 4 (optional), calibrator 5 (optional), calibrator 6 (optional); Packaging specifications for PA200: 50 servings/box, 100 servings/box, 150 servings/box, 200 servings/box, QC 1 (optional), QC 2 (optional), QC 3 (optional), calibrator 1 (optional), calibrator 2 (optional), calibrator 3 (optional), calibrator 4 (optional), calibrator 5 (optional), calibrator 6 (optional).PA480/PA480A/PA480C/PA480S;PA240/PA240A/PA240C/PA240S 用包装规格:25人份/盒、50人份/盒、100人份/盒、150人份/盒、200人份/盒、250人份/盒、300人份/盒,质控品1(选配)、质控品2(选配)、质控品3(选配)、校准品1(选配)、校准品2(选配)、校准品3(选配)、校准品4(选配)、校准品5(选配)、校准品6(选配);PA120用包装规格:50人份/盒、100人份/盒、150人份/盒、200人份/盒,质控品1(选配)、质控品2(选配)、质控品3(选配)、校准品1(选配)、校准品2(选配)、校准品3(选配)、校准品4(选配)、校准品5(选配)、校准品6(选配);PA200用包装规格:50人份/盒、100人份/盒、150人份/盒、200人份/盒,质控品1(选配)、质控品2(选配)、质控品3(选配)、校准品1(选配)、校准品2(选配)、校准品3(选配)、校准品4(选配)、校准品5(选配)、校准品6(选配)。
- Approval department
- Guangdong Provincial Drug Administration广东省药品监督管理局
- Registration number
- 粤械注准20242401300
- Approval date
- September 27, 2024
- Expiry date
- September 26, 2029
- Name
- Genrui Biotech Inc.深圳市锦瑞生物科技股份有限公司
- Province/Region
- Guangdong广东
- Address
- Shenzhen Guangming New District Matian Street Ma Shantou Community Watch Base Geya Science and Technology Park Building 3 4 to 10 floors深圳市光明新区马田街道马山头社区钟表基地格雅科技园3栋4至10层
- Production address
- 深圳市光明新区马田办事处马山头社区钟表基地格雅科技园3栋4至10层;深圳市光明区马田街道合水口社区第七工业区第三栋厂房A801;广东省东莞市黄江镇田星路39号2栋501室(仅为仓库使用)
It is suitable for in vitro quantitative detection of antistreptolysin O (ASO) content in human serum or plasma. Clinically, it is mainly used as an auxiliary diagnosis of acute rheumatic fever.
适用于体外定量检测人血清或血浆中的抗链球菌溶血素 O(ASO)含量。临床上主要用于急性风湿热的辅助诊断。
1. Buffer: phosphate buffer 20 mmol/L, preservative 0.1%; 2. Antiserum: latex granules of streptococcal hemolysin O; 3 Quality control (optional): ASO diluted in PBS buffer containing BSA; 4 calibrators (optional): ASO diluted in PBS buffer containing BSA; 5 Magnetic card: load the calibration curve information of this batch of reagents.
1缓冲液:磷酸盐缓冲液20 mmol/L,防腐剂0.1%; 2抗血清:链球菌溶血素O的胶乳颗粒; 3质控品(选配):ASO稀释于含BSA的PBS缓冲液; 4校准品(选配):ASO稀释于含BSA的PBS缓冲液; 5磁卡:载入本批次试剂的定标曲线信息。
Before the kit is opened, all reagents can be stored at 2-8°C in the dark for 18 months and cannot be frozen. The kit is stable for 30 days when stored at 2-8°C after opening; PA120 is stable for 7 days after the reagent is opened, with antiserum in machine (2-15°C) and buffer in machine (2-30°C); Other applicable instruments are powered on, and the buffer and antiserum are on the machine (2-15°C) after the reagent is opened, and can be stable for 7 days.
试剂盒未开启前,所有试剂避光储存于 2-8℃,可保存 18 个月,不可冷冻。试剂盒开启后保存于 2-8℃,可稳定 30 天;PA120 开机状态下,试剂开封后抗血清在机(2-15℃),缓冲液在机(2-30℃),可稳定 7 天;其他适用仪器开机状态下,试剂开封后缓冲液和抗血清在机(2-15℃),可稳定 7 天。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Anti-streptolysin O (ASO) Assay Kit (Timed Scatter Turbidimetry) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 粤械注准20242401300 and owned by Genrui Biotech Inc.. The device was approved on September 27, 2024.
This page provides complete registration details including registrant information, province location (Guangdong), 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.