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China NMPA legacy archive 粤械注准20242401300

Anti-streptolysin O (ASO) Assay Kit (Timed Scatter Turbidimetry)

抗链球菌溶血素O(ASO)测定试剂盒(定时散射比浊法)
Genrui Biotech Inc.Class IINMPAApproved September 27, 2024
Static archiveNMPA · legacy registration snapshot
Device classification
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 information
Registration number
粤械注准20242401300
Approval date
September 27, 2024
Expiry date
September 26, 2029
Registrant
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 facility
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)
Intended use
English

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.

中文

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。

Structure and composition
English

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.

中文

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。

Storage conditions and expiration
English

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.

中文

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。

Additional information
Appendix
产品技术要求、说明书
About this record

This static archive preserves historical registration fields and translations for Anti-streptolysin O (ASO) Assay Kit (Timed Scatter Turbidimetry), registration 粤械注准20242401300. It does not establish current authorization or complete current product details.

The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.