Tumor-Associated Antigen 242 Determination Reagent Kit (Chemiluminescence Immunoassay)
- Device class
- Class II
- Model specifications
- 100 servings/box, 200 servings/box.
- Approval department
- Jiangsu Provincial Drug Administration
- Registration number
- 苏械注准20242400348
- Approval date
- March 12, 2024
- Expiry date
- August 25, 2029
- Province/Region
- Jiangsu
- Address
- Room 501, Building B11, Bionanopark, No. 218 Xinghu Street, Suzhou Industrial Park
- 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
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.
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。
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.
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。
Store at 2~8°C, valid for 18 months; Opened reagents and calibrators are stable for 60 days at 2-8°C.
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。
- Remark
- 原注册证号:国械注准20193400643
- Appendix
- 产品技术要求、说明书
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