China NMPA legacy archive 湘械注准20232400820Prealbumin (PA) Assay Kit (Immunoturbidimetry)
- Device class
- Class II
- Model specifications
- Reagents: 100mL×8/80mL×2, 100mL×4/80mL×1, 100mL×3/60mL×1, 100mL×2/40mL×1, 100mL×1/20mL×1, 80mL×8/64mL×2, 80mL×4/64mL×1, 80mL×3/48mL×1, 80mL×2/32mL×1, 80mL×1/16mL×1, 80mL×6/16mL×6, 80mL×5/16mL×5、80mL×4/16mL×4、80mL×3/16mL×3、80mL×2/16mL×2、60mL×6/12mL×6、60mL×5/12mL×5、60mL×4/12mL×4、60mL×3/12mL×3、60mL×2/12mL×2、60mL×1/12mL×1、50mL×5/10mL×5 、50mL×4/10mL×4、 50mL×3/10mL×3、50mL×2/10mL×2、50mL×1/10 mL×1、45mL×8/18mL×4、45mL×6/18mL×3、45mL×4/18mL×2、45mL×2/18mL×1、45mL×1/9mL×1、40mL×5/20mL×2、40mL×4/16mL×2、 40mL×3/12mL×2、40mL×2/16mL×1、 40mL×1/8mL×2、20mL×5/4mL×5、20mL×4/4mL×4、20mL×3/4mL×3、20mL×2/4mL×2、20mL×1/4mL×1、120mL×1/24mL×1、500mL×2/100mL×2、500mL×4/100mL×4; 4×400T; 380T; 2×710T; 2×505T; 4×460T; 2×460T; 2×400T; 1×400T; 2×260T (reagent 1:2×60mL + reagent 2:2×20mL); 12×52T (reagent 1:12×16.8mL + reagent 2:12×5.8mL); 12×52T (reagent 1: 12×17.2mL + reagent 2: 12×6.0mL); 1×52T (reagent 1:1×17.2mL + reagent 2:1×6.0mL); 1×200T (reagent 1:1× (15.5mL + 23.5mL) + reagent 2: 1×13mL); 4×200T (reagent 1:4 (15.5mL + 23.5mL) + reagent 2:4×13mL); 1000T (reagent 1:2×60mL + reagent 2:1×40mL); 1000T (reagent 1:2× 500T + reagent 2:1×1000T); Calibrator (optional): 0.5mL×1, 1mL×1, 2mL×1; Controls (optional): 0.5mL×1, 1mL×1, 2mL×1.
- Approval department
- Hunan Provincial Drug Administration
- Registration number
- 湘械注准20232400820
- Approval date
- August 31, 2023
- Expiry date
- August 30, 2028
- Province/Region
- Hunan
- Address
- No. 101, Kangtian Road, Liuyang Economic and Technological Development Zone
- Production address
- 浏阳经济技术开发区康天路101号
It is used for in vitro quantitative determination of the concentration of PA in human serum.
用于体外定量测定人血清中PA的浓度。
Reagent 1: Tris-HCl buffer 6g/L, polyethylene glycol-6000 60g/L, Tween 20 1g/L, disodium phosphate 9g/L;Reagent 2: Tris-HCl buffer 15g/L, sodium chloride 10g/L, sodium azide 1g/L, prealbumin antibody 90g/L;calibrator concentration range: [level 1: 400mg/L-700mg/L], different amounts of PA antigen, Proclin300 1mL, BSA 10g; The concentration range of the quality control substance: [level 1: 200mg/L-500mg/L], different amounts of PA antigen, Proclin300 1mL, and BSA 10g were added.
试剂1:Tris-HCl缓冲液 6g/L、聚乙二醇-6000 60g/L、吐温20 1g/L、磷酸氢二钠 9g/L;试剂 2:Tris-HCl缓冲液 15g/L、氯化钠 10g/L、叠氮钠 1g/L、 前白蛋白抗体 90g/L;校准品浓度范围:【水平1:400mg/L-700mg/L】,添加了不同量PA抗原、Proclin300 1mL、BSA 10g;质控品浓度范围:【水平1:200mg/L-500mg/L】,添加了不同量PA抗原、Proclin300 1mL、BSA 10g。
Reagents, calibrators and quality controls should be sealed and stored at 2°C~8°C and protected from light, with a validity period of 12 months, and the reagents can be stable for 28 days at 2°C~8°C after opening the bottle, and the calibrators and quality controls can be stable for 3 days at 2°C-8°C after opening the bottle.
试剂及校准品、质控品在2℃～8℃密封避光保存，有效期12个月；已开瓶试剂注意避免污染，在 2℃～8℃下可稳定28天；校准品、质控品开瓶后2℃-8℃可稳定3天。
- Appendix
- 产品技术要求、说明书
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