China NMPA legacy archive 鄂械注准20242405097Creatinine assay kit (creatine oxidase method)
- Device class
- Class II
- Model specifications
- Reagent 1: 60mL×3, Reagent 2: 60mL×1, Reagent 1: 24mL×1, Reagent 2: 8mL×1, Reagent 1: 90mL×2, Reagent 2: 60mL×1; Reagent 1: 50mL×3, Reagent 2: 50mL×1, Reagent 1: 60mL×1, Reagent 2: 20mL×1, Reagent 1: 60mL×2, Reagent 2: 20mL×2, Reagent 1: 40mL×3, Reagent 2: 40mL×1, Reagent 1: 60mL×6, Reagent 2: 60mL×2; Reagent 1: 60mL×9, Reagent 2: 60mL×3; Reagent 1: 6×64 test/box, Reagent 2: 6×64 test/box; Reagent 1: 12×64 test/box, Reagent 2: 12×64 test/box; Reagent 1:1×530 test/box, Reagent 2:1×530 test/box; Reagent 1:2×530 test/box, Reagent 2:2×530 test/box; Reagent 1: 3×530 test/box, Reagent 2: 3×530 test/box; Reagent 1: 6×530 test/box, Reagent 2: 6×530 test/box; Reagent 1:9×530 test/box, Reagent 2:9×530 test/box; Reagent 1:1×180 test/box, Reagent 2:1×180 test/box;
- Approval department
- Hubei Provincial Drug Administration
- Registration number
- 鄂械注准20242405097
- Approval date
- July 25, 2024
- Expiry date
- July 24, 2029
- Province/Region
- Hubei
- Address
- 1st, 2nd and 3rd floor, No. 818 Gaoxin Avenue, Wuhan East Lake New Technology Development Zone, No. 818 High-tech Medical Equipment Park
- Production address
- 武汉东湖新技术开发区高新大道818号高科医疗器械园B11号1楼、3楼
This product is used for the quantitative determination of creatinine content in human serum, plasma and urine in vitro.
本品用于体外定量测定人体血清、血浆、尿液中肌酐的含量。
Reagent 1: 1,4-piperazine dieethanesulfonic acid; imidazolidinylurea; creatine amimidine hydrolase; sarcosine oxidase; ascorbate oxidase; Catalase; 4-Aminoantipyrine; Reagent 2: 1,4-piperazine dieethanesulfonic acid; Sodium azide; N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3-methylaniline sodium salt; Peroxidase; Creatinine aminolylase. (Please refer to the product manual for details)
试剂1：1,4-哌嗪二乙磺酸；咪唑烷基脲；肌酸脒基水解酶；肌氨酸氧化酶；抗坏血酸氧化酶；过氧化氢酶；4-氨基安替比林；试剂2：1,4-哌嗪二乙磺酸；叠氮化钠；N-乙基-N-(2-羟基-3-磺丙基)-3-甲基苯胺钠盐；过氧化物酶；肌酐酰氨基水解酶。（具体内容详见产品说明书）
This product can be sealed at 2°C~8°C and stored in the dark for 16 months.
本品于2℃～8℃密封避光储存可稳定16个月。
- Appendix
- 产品技术要求、说明书
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