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China NMPA legacy archive 苏械注准20242400348

Tumor-Associated Antigen 242 Determination Reagent Kit (Chemiluminescence Immunoassay)

肿瘤相关抗原242测定试剂盒(化学发光免疫分析法)
Suzhou Lihe Biomedical Engineering Co., Ltd.Class IINMPAApproved March 12, 2024
Static archiveNMPA · legacy registration snapshot
Device classification
Device class
Class II
Model specifications
100 servings/box, 200 servings/box.
100人份/盒,200人份/盒。
Approval department
Jiangsu Provincial Drug Administration
江苏省药品监督管理局
Registration information
Registration number
苏械注准20242400348
Approval date
March 12, 2024
Expiry date
August 25, 2029
Registrant
Name
Suzhou Lihe Biomedical Engineering Co., Ltd.
苏州立禾生物医学工程有限公司
Province/Region
Jiangsu
江苏
Address
Room 501, Building B11, Bionanopark, No. 218 Xinghu Street, Suzhou Industrial Park
苏州工业园区星湖街218号生物纳米园B11号楼501室
Production facility
Production address
苏州工业园区星湖街218号生物纳米园B11号楼4楼、5楼,苏州工业园区星湖街218号生物纳米园B11号楼3楼,苏州市工业园区赵家上路7号
Intended use
English

It is used for the quantitative determination of the concentration of tumor-associated antigen 242 in human serum in vitro, and is clinically used for the monitoring of the efficacy of pancreatic cancer, colorectal cancer and gastrointestinal malignant tumors.

中文

用于体外定量测定人血清中肿瘤相关抗原242的浓度,临床上用于胰腺癌、结直肠癌消化道恶性肿瘤的疗效监测,不能作为恶性肿瘤早期诊断或确诊的依据,不能用于普通人群的肿瘤筛查。

Structure and composition
English

Reagent 1: Biotinylated anti-tumor-associated antigen 242 monoclonal antibody (approximately 0.5 mg/L, murine derived), tris-hydroxymethyl aminomethane buffer (containing bovine serum protein, 0.1% Proclin300); Reagent 2: acridine ester-labeled anti-tumor-associated antigen 242 monoclonal antibody (about 0.5 mg/L, murine derived), tris-hydroxymethyl aminomethane buffer (containing bovine serum protein, 0.1% Proclin300); Reagent M: Streptavidin-coated magnetic particles (about 0.3 mg/mL), treated with antiseptic; Calibrated Substance: Contains tumor-associated antigen 242 (human-derived), phosphate buffered saline (contains bovine serum protein, 0.1% Proclin300); The concentrations are approximately: 0, 5, 15, 50, 150, 300U/mL, traceable to the company's internal calibrators.

中文

试剂1:含生物素标记的抗肿瘤相关抗原242单克隆抗体(约0.5mg/L,鼠源性),三羟甲基氨基甲烷缓冲液(含牛血清蛋白,0.1% Proclin300);试剂2:含吖啶酯标记的抗肿瘤相关抗原242单克隆抗体(约0.5mg/L,鼠源性),三羟甲基氨基甲烷缓冲液(含牛血清蛋白,0.1% Proclin300);试剂M:含链霉亲和素包被的磁颗粒(约0.3mg/mL),经防腐处理;校准品:含肿瘤相关抗原242(人源性),磷酸盐缓冲液(含牛血清蛋白,0.1% Proclin300);浓度分别约为:0、5、15、50、150、300U/mL,溯源至企业内部校准品。

Storage conditions and expiration
English

Store at 2~8°C, valid for 18 months; Opened reagents and calibrators are stable for 60 days at 2-8°C.

中文

2~8℃保存,有效期18个月;开封的试剂及校准品,2-8℃环境下可稳定保存60天。

Additional information
Remark
原注册证号:国械注准20193400643
Appendix
产品技术要求、说明书
About this record

This static archive preserves historical registration fields and translations for Tumor-Associated Antigen 242 Determination Reagent Kit (Chemiluminescence Immunoassay), registration 苏械注准20242400348. 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.