安徽省食品药品监督管理局核发《医疗器械注册证书》公示(2012年第29号)

中国好中医 40 2023-12-25 08:06:39

安徽省食品药品监督管理局核发《医疗器械注册证书》公示(2012年第29号)  

 

根据《中华人民共和国行政许可法》和国家食品药品监督管理局《医疗器械注册管理办法》和《体外诊断试剂医疗器械注册管理办法(试行)》规定,经技术审评和行政审查,符合要求。我局拟对安徽伊普诺康生物工程有限公司43个产品(详见附件)第二类医疗器械首次注册核发注册证书,现予以公示。公示期自2012年09月25日至2012年10月04日,请社会各界予以监督。

监督电话:0551-2999261

地   址:合肥市马鞍山路与太湖路交叉口省政务大厦

安徽省食品药品监督管理局医疗器械监管处

邮政编码:230051

电子邮箱:qxjgc@ada.gov.cn

 

                                             安徽省食品药品监督管理局

                                                  2012年9月25日

附件:

 

产品名称

1、天冬氨酸氨基转移酶测定试剂盒(速率法)

规格型号

R1:1×40ml,R2:1×20ml 、R1:2×40ml,R2:2×20ml、R1:2×60ml,R2:2×30ml、R1:3×40ml,R2:3×20ml、R1: 4×50ml,R2:2×50ml、R1:4×60ml,R2:2×60ml、R1:2×100ml,R2:1×100ml、R1:5×60ml,R2:3×50ml、R1:6×60ml,R2:3×60ml、R1:4×50ml,R2:2×35mlR1:4×50ml,R2:2×25ml、R1:1×4000ml,R2:1×2000ml、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R1Tris缓冲液、NADH、LDH、MDH 

R2:Tris缓冲液、L-天门冬氨酸、α-酮戊二酸

预期用途

用于体外定量测定人血清中天冬氨酸氨基转移酶的含量。

产品名称

2、丙氨酸氨基转移酶测定试剂盒(速率法)

规格型号

R1:1×40ml,R2:1×20ml 、R1:2×40ml,R2:2×20ml、R1:2×60ml,R2:2×30ml、R1:3×40ml,R2:3×20ml、R1:4×50ml,R2:2×50ml、R1:4×60ml,R2:2×60ml、R1:2×100ml,R2:1×100ml、R1:5×60ml,R2:3×50ml、R1:6×60ml,R2:3×60ml、R1:4×50ml,R2:2×35mlR1:4×50ml,R2:2×25ml、R1:1×4000ml,R2:1×2000ml、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R1Tris缓冲液、NADH、LDH

R2:Tris缓冲液、L-丙氨酸、α-酮戊二酸

预期用途

用于体外定量测定人血清中丙氨酸氨基转移酶的含量。

产品名称

3、γ-谷氨酰基转移酶测定试剂盒(速率法)

规格型号

R1:1×40ml,R2:1×10ml、R1:1×60ml,R2:1×15ml、R1:2×60ml,R2:2×15ml、R1:4×50ml,R2:2×25ml、R1:4×60ml,R2:4×15ml、R1:6×40ml,R2:3×20ml、R1:2×100ml,R2:1×50ml、R1:4×60ml,R2:1×60ml、R1:4×60ml,R2:2×30ml、R1:4×50ml,R2:2×35ml、R1:4×50ml,R2:2×50mlR1:1×4000ml,R2:1×1000ml、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R1Tris缓冲液、双甘肽

R2:L-γ-谷氨酰-3-羧基-4-硝基苯胺

预期用途

用于体外定量测定人血清中γ-谷氨酰基转移酶的含量。

产品名称

4、碱性磷酸酶测定试剂盒(速率法)

规格型号

R1:1×40ml,R2:1×10ml、R1:1×60ml,R2:1×15ml、R1:2×60ml,R2:2×15ml、R1:4×50ml,R2:2×25ml、R1:4×60ml,R2:4×15ml、R1:6×40ml,R2:3×20ml、R1:2×100ml,R2:1×50ml、R1:4×60ml,R2:1×60ml、R1:4×60ml,R2:2×30ml、R1:4×50ml,R2:2×35ml、R1:4×50ml,R2:2×50mlR1:1×4000ml,R2:1×1000ml、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R1AMP缓冲液、EDTA

R2:磷酸对硝基苯(4-NPP)

预期用途

用于体外定量测定人血清中碱性磷酸酶的含量。

产品名称

5、α-L-岩藻糖苷酶测定试剂盒(速率法)

规格型号

1×30mL、1×60mL、2×50mL、3×60mL、4×60mL、5×60mL、4×40mL、2×80mL、1×1000mL、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R:柠檬酸缓冲液、2-氯-4-硝基苯-α-L-岩藻糖苷(CNPF)

预期用途

用于体外定量测定人血清中α-L-岩藻糖苷酶的含量。

产品名称

6、血管紧张素转化酶测定试剂盒(速率法)

规格型号

1×30mL、1×60mL、2×50mL、3×60mL、4×60mL、5×60mL、4×40mL、2×80mL、1×1000mL、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R:Tris缓冲液、苯丙酰氨基双甘肽(FAPGG)

预期用途

用于体外定量测定人血清中血管紧张素转化酶的含量。

产品名称

7、甘氨酰脯氨酸二肽氨基肽酶测定试剂盒(速率法)

规格型号

R1:1×18ml,R2:1×6ml、R1:2×60ml,R2:2×20ml、R1:2×60ml,R2:1×40ml、R1:3×40ml,R2:2×20ml、R1:3×60ml,R2:1×60ml、R1:3×50ml,R2:1×50ml、R1:3×100ml,R2:1×100ml、R1:4×60ml,R2:2×40ml、R1:5×60ml,R2:2×50ml、R1:4×40ml,R2:2×40ml、R1:4×40ml,R2:1×40ml、R1:1×3000ml,R2:1×1000ml、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R1磷酸盐缓冲液

R2:Tris缓冲液、L-丙氨酸、α-酮戊二酸

预期用途

用于体外定量测定人血清中甘氨酰脯氨酸二肽氨基肽酶的含量。

产品名称

8、5’-核苷酸酶测定试剂盒(速率法)

规格型号

R1:1×18ml,R2:1×6ml、R1:2×60ml,R2:2×20ml、R1:2×60ml,R2:1×40ml、R1:3×40ml,R2:2×20ml、R1:3×60ml,R2:1×60ml、R1:3×50ml,R2:1×50ml、R1:3×100ml,R2:1×100ml、R1:4×60ml,R2:2×40ml、R1:5×60ml,R2:2×50ml、R1:4×40ml,R2:2×40ml、R1:4×40ml,R2:1×40ml、R1:1×3000ml,R2:1×1000ml、12×60Ts、注:特殊规格根据临床需求提供

主要组成成份

R1Good’s缓冲液、5’-IMP、黄嘌呤氧化酶(XOD)、嘌呤核苷酸氧化酶(PNP)

R2:过氧化物酶(POD)、4-氨基安替比林(4-AA)、TBHBA

预期用途

用于体外定量测定人血清中5’-核苷酸酶的含量。

产品名称

9、胆碱酯酶测定试剂盒(速率法)

规格型号

R1:1×40ml,R2:1×10ml、R1:1×60ml,R2:1×15ml、R1:2×60ml,R2:2×15ml、R1:4×50ml,R2:2×25ml、R1:4×60ml,R2:4×15ml、R1:6×40ml,R2:3×20ml、R1:2×100ml,R2:1×50ml、R1:4×60ml,R2:1×60ml、R1:4×60ml,R2:2×30ml、R1:4×50ml,R2:2×35ml、R1:4×50ml,R2:2×50mlR1:1×4000ml,R2:1×1000ml、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R1磷酸盐缓冲液、二硫代双硝基苯甲酸(DTNB)

R2:丁酰硫代胆碱

预期用途

用于体外定量测定人血清中胆碱酯酶的含量。

产品名称

10、尿素测定试剂盒(酶法)

规格型号

R1:1×40ml,R2:1×10ml、R1:1×60ml,R2:1×15ml、R1:2×60ml,R2:2×15ml、R1:4×50ml,R2:2×25ml、R1:4×60ml,R2:4×15ml、R1:6×40ml,R2:3×20ml、R1:2×100ml,R2:1×50ml、R1:4×60ml,R2:1×60ml、R1:4×60ml,R2:2×30ml、R1:4×50ml,R2:2×35ml、R1:4×50ml,R2:2×50mlR1:1×4000ml,R2:1×1000ml、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R1Tris缓冲液、NADH、α-酮戊二酸

R2:Tris缓冲液、谷氨酸脱氢酶、脲酶

预期用途

用于体外定量测定人血清中尿素的含量。

产品名称

11、肌酸激酶测定试剂盒(速率法)

规格型号

R1:1×40ml,R2:1×10ml、R1:1×60ml,R2:1×15ml、R1:2×60ml,R2:2×15ml、R1:4×50ml,R2:2×25ml、R1:4×60ml,R2:4×15ml、R1:6×40ml,R2:3×20ml、R1:2×100ml,R2:1×50ml、R1:4×60ml,R2:1×60ml、R1:4×60ml,R2:2×30ml、R1:4×50ml,R2:2×35ml、R1:4×50ml,R2:2×50mlR1:1×4000ml,R2:1×1000ml、12×60Ts、注:特殊规格根据临床需求提供

主要组成成份

R1咪唑缓冲液、GLU、ADP、NADP、NAC、HK、G-6-PD

R2:咪唑缓冲液、CrP

预期用途

用于体外定量测定人血清中肌酸激酶的含量。

产品名称

12、肌酸激酶同工酶测定试剂盒(速率法)

规格型号

R1:1×24ml,R2:1×6ml、R1:1×60ml,R2:1×15ml、R1:2×60ml,R2:2×15ml、R1:4×50ml,R2:2×25ml、R1:4×60ml,R2:4×15ml、R1:6×40ml,R2:3×20ml、R1:2×100ml,R2:1×50ml、R1:4×60ml,R2:1×60ml、R1:4×60ml,R2:2×30ml、R1:4×50ml,R2:2×35ml、R1:4×50ml,R2:2×50ml、R1:1×4000ml,R2:1×1000ml、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R1:咪唑缓冲液、GLU、ADP、NADP、NAC、HK、G-6-PD、CK-M抗体

R2:咪唑缓冲液、CrP 

预期用途

用于体外定量测定人血清中肌酸激酶同工酶的含量。

产品名称

13、乳酸脱氢酶测定试剂盒(速率法)

规格型号

R1:1×40ml,R2:1×10ml、R1:1×60ml,R2:1×15ml、R1:2×60ml,R2:2×15m、R1:4×50ml,R2:2×25ml、R1:4×60ml,R2:4×15ml、R1:6×40ml,R2:3×20ml、R1:2×100ml,R2:1×50ml、R1:4×60ml,R2:1×60ml、R1:4×60ml,R2:2×30ml、R1:4×50ml,R2:2×35ml、R1:4×50ml,R2:2×50ml、R1:1×4000ml,R2:1×1000ml、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R1: Tris缓冲液、乳酸锂

R2: Tris缓冲液、NAD+

预期用途

用于体外定量测定人血清中乳酸脱氢酶的含量。

产品名称

14、同型半胱氨酸测定试剂盒(酶循环法)

规格型号

R1:1×30ml,R2:1×6ml、R1:1×50ml,R2:1×10ml、R1:2×50ml,R2:2×10ml、R1:4×50ml,R2:2×20ml、R1:5×40ml,R2:1×40ml、R1:4×60ml,R2:3×48ml、R1:2×100ml,R2:1×40ml、R1:4×60ml,R2:1×60ml、R1:4×40ml,R2:2×20ml、R1:4×50ml,R2:2×25ml、R1:4×60ml,R2:2×30ml、R1:1×4000ml,R2:1×1000ml、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R1: S-腺苷甲硫氨酸(SAM)、NADPH、TCEP、α-酮戊二酸

R2: HCY甲基转移酶、谷氨酸脱氢酶(GLDH)、S-腺苷同型半胱氨酸水解酶

预期用途

用于体外定量测定人血清中同型半胱氨酸的含量。

产品名称

15、腺苷脱氨酶测定试剂盒(速率法)

规格型号

R1:1×24ml,R2:1×6ml、R1:2×60ml,R2:2×20ml、R1:2×60ml,R2:1×40ml、R1:3×40ml,R2:2×20ml、R1:3×60ml,R2:1×60ml、R1:3×50ml,R2:1×50ml、R1:3×100ml,R2:1×100ml、R1:4×60ml,R2:2×40ml、R1:5×60ml,R2:2×50ml、R1:4×40ml,R2:2×40ml、R1:4×40ml,R2:1×40ml、R1:1×3000ml,R2:1×1000ml、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R1: Good’s缓冲液、腺苷、黄嘌呤氧化酶(XOD)、嘌呤核苷酸氧化酶(PNP)

R2: 过氧化物酶(POD)、4-氨基安林比林(4-AA)、TOOS

预期用途

用于体外定量测定人血清中腺苷脱氨酶的含量。

产品名称

16、α-羟丁酸脱氢酶测定试剂盒(速率法)

规格型号

R1:1×40ml,R2:1×10ml、R1:1×60ml,R2:1×15ml、R1:2×60ml,R2:2×15ml、R1:4×50ml,R2:2×25ml、R1:4×60ml,R2:4×15ml、R1:6×40ml,R2:3×20ml、R1:2×100ml,R2:1×50ml、R1:4×60ml,R2:1×60ml、R1:4×60ml,R2:2×30ml、R1:4×50ml,R2:2×35ml、R1:4×50ml,R2:2×50ml、R1:1×4000ml,R2:1×1000ml、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R1: 磷酸盐缓冲液、α-酮丁酸

R2: 磷酸盐缓冲液、NADH

预期用途

用于体外定量测定人血清中α-羟丁酸脱氢酶的含量。

产品名称

17、总胆汁酸测定试剂盒(酶循环法)

规格型号

R1:1×18ml,R2:1×6ml、R1:2×60ml,R2:2×20ml、R1:2×60ml,R2:1×40ml、R1:3×40ml,R2:2×20ml、R1:3×60ml,R2:1×60ml、R1:3×50ml,R2:1×50ml、R1:3×100ml,R2:1×100ml、R1:4×60ml,R2:2×40ml、R1:5×60ml,R2:2×50ml、R1:4×40ml,R2:2×40ml、R1:4×40ml,R2:1×40ml、R1:1×3000ml,R2:1×1000ml、12×60Ts、注:特殊规格根据临床需求提供

主要组成成份

R1: Good’s缓冲液、硫代-NAD

R2: Good’s缓冲液、3α-HSD、NADH

预期用途

用于体外定量测定人血清中总胆汁酸的含量。

产品名称

18、高密度脂蛋白胆固醇测定试剂盒(直接法)

规格型号

R1:1×18ml,R2:1×6ml、R1:2×60ml,R2:2×20ml、R1:2×60ml,R2:1×40ml、R1:3×40ml,R2:2×20ml、R1:3×60ml,R2:1×60ml、R1:3×50ml,R2:1×50ml、R1:3×100ml,R2:1×100ml、R1:4×60ml,R2:2×40ml、R1:5×60ml,R2:2×50ml、R1:4×40ml,R2:2×40ml、R1:4×40ml,R2:1×40ml、R1:1×3000ml,R2:1×1000ml、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R1: GOODS缓冲液、胆固醇氧化酶、、胆固醇脂酶、表面活性剂

R2: GOODS缓冲液、过氧化物酶、HSDA、4-氨基安替比林、表面活性剂

预期用途

用于体外定量测定人血清中高密度脂蛋白胆固醇的含量。

产品名称

19、低密度脂蛋白胆固醇测定试剂盒(直接法)

规格型号

R1:1×18ml,R2:1×6ml、R1:2×60ml,R2:2×20ml、R1:2×60ml,R2:1×40ml、R1:3×40ml,R2:2×20ml、R1:3×60ml,R2:1×60ml、R1:3×50ml,R2:1×50ml、R1:3×100ml,R2:1×100ml、R1:4×60ml,R2:2×40ml、R1:5×60ml,R2:2×50ml、R1:4×40ml,R2:2×40ml、R1:4×40ml,R2:1×40ml、R1:1×3000ml,R2:1×1000ml、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R1: GOODS缓冲液、胆固醇氧化酶、、胆固醇脂酶、聚阴离子、表面活性剂

R2: GOODS缓冲液、过氧化物酶、HSDA、4-氨基安替比林、表面活性剂

预期用途

用于体外定量测定人血清中低密度脂蛋白胆固醇的含量。

产品名称

20、甘油三酯测定试剂盒(氧化酶法)

规格型号

R1:1×40ml,R2:1×20ml、R1:2×60ml,R2:2×30ml、R1:2×60ml,R2:1×60ml、R1:3×40ml,R2:3×20ml、R1:3×60ml,R2:3×30ml、R1:3×50ml,R2:3×25ml、R1:3×100ml,R2:1×150ml、R1:4×60ml,R2:2×40ml、R1:5×60ml,R2:2×50ml、R1:3×50ml,R2:2×25ml、R1:3×40ml,R2:2×20ml、R1:1×3000ml,R2:1×1000ml、12×60Ts、注:特殊规格根据临床需求提供

主要组成成份

R1: GOODS缓冲液、甘油磷酸氧化酶、甘油激酶、4-氨基安替比林、ATP

R2: GOODS缓冲液、脂蛋白脂酶、过氧化物酶、TOOS

预期用途

用于体外定量测定人血清中甘油三酯的含量。

产品名称

21、总胆固醇测定试剂盒(氧化酶法)

规格型号

R1:1×40ml,R2:1×20ml、R1:2×60ml,R2:2×30ml、R1:2×60ml,R2:1×60ml、R1:3×40ml,R2:3×20ml、R1:3×60ml,R2:3×30ml、R1:3×50ml,R2:3×25ml、R1:3×100ml,R2:1×150ml、R1:4×60ml,R2:2×40ml、R1:5×60ml,R2:2×50ml、R1:3×50ml,R2:2×25ml、R1:3×40ml,R2:2×20ml、R1:1×3000ml,R2:1×1000ml、12×60Ts注:特殊规格根据临床需求提供。

主要组成成份

R1: MOPSO缓冲液、胆固醇酯酶、4-氨基安替比林

R2: 胆固醇氧化酶、对羟基苯甲酸钠、过氧化物酶

预期用途

用于体外定量测定人血清中总胆固醇的含量。

产品名称

22、肌酐测定试剂盒(酶法)

规格型号

R1:1×18ml,R2:1×6ml、R1:2×60ml,R2:2×20ml、R1:2×60ml,R2:1×40ml、R1:3×40ml,R2:2×20ml、R1:3×60ml,R2:1×60ml、R1:3×50ml,R2:1×50ml、R1:3×100ml,R2:1×100ml、R1:4×60ml,R2:2×40ml、R1:5×60ml,R2:2×50ml、R1:4×40ml,R2:2×40ml、R1:4×40ml,R2:1×40ml、R1:1×3000ml,R2:1×1000ml、12×60Ts、注:特殊规格根据临床需求提供

主要组成成份

R1: GOODS缓冲液、肌酸酶、肌氨酸氧化酶、TOOS

R2: GOODS缓冲液、肌酐酶、过氧化物酶、4-氨基安替比林

预期用途

用于体外定量测定人血清中肌酐的含量。

产品名称

23、肌钙蛋白I测定试剂盒(免疫比浊法)

规格型号

R1:1×18ml,R2:1×6ml、R1:1×30ml,R2:1×10ml、R1:2×60ml,R2:1×40ml、R1:3×40ml,R2:2×20ml、R1:3×60ml,R2:1×60ml、R1:3×50ml,R2:1×50ml、R1:3×100ml,R2:1×100ml、R1:4×60ml,R2:2×40ml、R1:5×60ml,R2:2×50ml、R1:4×40ml,R2:2×40ml、R1:4×40ml,R2:1×40ml、R1:1×3000ml,R2:1×1000ml、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R1: Tris缓冲液、PEG-8000

R2: 乳胶包被抗人肌钙蛋白I抗体

预期用途

用于体外定量测定人血清中肌钙蛋白I的含量。

产品名称

24、葡萄糖测定试剂盒(氧化酶法)

规格型号

R1:1×40ml,R2:1×10ml、R1:1×60ml,R2:1×15ml、R1:2×60ml,R2:2×15ml、R1:4×50ml,R2:2×25ml、R1:4×60ml,R2:4×15ml R1:6×40ml,R2:3×20ml、R1:2×100ml,R2:1×50ml、R1:4×60ml,R2:1×60ml、R1:4×60ml,R2:2×30ml、R1:4×50ml,R2:2×35ml、R1:4×50ml,R2:2×50ml、R1:1×4000ml,R2:1×1000ml、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R1: 磷酸盐缓冲液、葡萄糖氧化酶、4-氨基安替比林

R2: 磷酸盐缓冲液、过氧化物酶、对羟基苯甲酸钠

预期用途

用于体外定量测定人血清中葡萄糖的含量。

产品名称

25、糖化血清蛋白测定试剂盒(NBT法)

规格型号

R1:1×30ml,R2:1×10ml、R1:1×60ml,R2:1×20ml、R1:2×60ml,R2:2×20ml、R1:4×50ml,R2:2×33ml、R1:4×60ml,R2:4×20ml、R1:6×40ml,R2:2×40ml、R1:2×100ml,R2:1×66ml、R1:4×60ml,R2:1×60ml、R1:4×60ml,R2:2×30ml、R1:4×50ml,R2:2×25ml 、R1:4×40ml,R2:1×40ml、R1:1×4000ml,R2:1×1000ml、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R1: 磷酸盐缓冲液

R2: 磷酸盐缓冲液、四氮唑蓝(NBT)

预期用途

用于体外定量测定人血清中糖化血清蛋白的含量。

产品名称

26、二氧化碳测定试剂盒(酶法)

规格型号

1×30mL、1×60mL、2×50mL、3×60mL、4×60mL、5×60mL、4×40mL、2×80mL、1×1000mL、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R: 磷酸烯醇丙酮酸、磷酸烯醇丙酮酸羧化酶、苹果酸脱氢酶、NADH

预期用途

用于体外定量测定人血清中二氧化碳的含量。

产品名称

27、尿酸测定试剂盒(酶法)

规格型号

R1:1×40ml,R2:1×10ml、R1:1×60ml,R2:1×15ml、R1:2×60ml,R2:2×15ml、R1:4×50ml,R2:2×25ml、R1:4×60ml,R2:4×15ml、R1:6×40ml,R2:3×20ml、R1:2×100ml,R2:1×50ml、R1:4×60ml,R2:1×60ml、R1:4×60ml,R2:2×30ml、R1:4×50ml,R2:2×35ml、R1:4×50ml,R2:2×50ml、R1:1×4000ml,R2:1×1000ml、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R1: 磷酸盐缓冲液、过氧化物酶、抗坏血酸氧化酶、4-氨基安替比林

R2: 磷酸盐缓冲液、尿酸酶、TOOS

预期用途

用于体外定量测定人血清中尿酸的含量。

产品名称

28、游离脂肪酸测定试剂盒(酶法)

规格型号

R1:1×20ml,R2:1×10ml、R1:2×40ml,R2:2×20ml、R1:2×60ml,R2:2×30ml、R1:3×40ml,R2:3×20ml、R1:4×50ml,R2:2×50ml、R1:4×60ml,R2:2×60ml、R1:2×100ml,R2:1×100ml、R1:5×60ml,R2:3×50ml、R1:6×60ml,R2:3×60ml、R1:4×50ml,R2:2×35ml、R1:4×50ml,R2:2×25ml、R1:1×4000ml,R2:1×2000ml、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R1:磷酸盐缓冲液、脂酰辅酶A(ACS)、辅酶A(CoA)、腺苷-5’-水合三磷酸二钠(ATP)、4-氨基安替比林、抗坏血酸氧化酶

R2: 脂酰辅酶A氧化酶(ACOD)、过氧化物酶(POD)、3-甲基-N-乙基-N-苯胺(MEHA)

预期用途

用于体外定量测定人血清中游离脂肪酸的含量。

产品名称

29、载脂蛋白A1测定试剂盒(免疫比浊法)

规格型号

R1:1×18ml,R2:1×6ml、R1:2×60ml,R2:2×20ml、R1:2×60ml,R2:1×40ml、R1:3×40ml,R2:2×20ml、R1:3×60ml,R2:1×60ml、R1:3×50ml,R2:1×50ml、R1:3×100ml,R2:1×100ml、R1:4×60ml,R2:2×40ml、R1:5×60ml,R2:2×50ml、R1:4×40ml,R2:2×40ml、R1:4×40ml,R2:1×40ml、R1:1×3000ml,R2:1×1000ml、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R1: Tris缓冲液、PEG-8000

R2: 抗载脂蛋白A1抗体

预期用途

用于体外定量测定人血清中载脂蛋白A1的含量。

产品名称

30、载脂蛋白B测定试剂盒(免疫比浊法)

规格型号

R1:1×18ml,R2:1×6ml、R1:2×60ml,R2:2×20ml、R1:2×60ml,R2:1×40ml、R1:3×40ml,R2:2×20ml、R1:3×60ml,R2:1×60ml、R1:3×50ml,R2:1×50ml、R1:3×100ml,R2:1×100ml、R1:4×60ml,R2:2×40ml、R1:5×60ml,R2:2×50ml、R1:4×40ml,R2:2×40ml、R1:4×40ml,R2:1×40ml、R1:1×3000ml,R2:1×1000ml、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R1: Tris缓冲液、PEG-8000

R2: 抗载脂蛋白B抗

预期用途

用于体外定量测定人血清中载脂蛋白B的含量。

产品名称

31、脂蛋白(a)测定试剂盒(免疫比浊法)

规格型号

R1:1×42ml,R2:1×6ml、R1:2×60ml,R2:1×18ml、R1:3×60ml,R2:2×13ml、R1:4×50ml,R2:2×15ml、R1:4×40ml,R2:2×12ml、R1:4×60ml,R2:1×35ml、R1:4×60ml,R2:2×18ml、R1:6×40ml,R2:2×18ml、R1:1×4000ml,R2:1×1000ml、R1:2×60ml,R2:2×15ml、R1:4×60ml,R2:4×15ml、R1:6×40ml,R2:3×20ml、R1:4×60ml,R2:1×60ml、R1:4×60ml,R2:2×32ml、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R1: Tris缓冲液、PEG-8000

R2: 抗脂蛋白(a)抗体

预期用途

用于体外定量测定人血清中脂蛋白(a)的含量。

产品名称

32、载脂蛋白E测定试剂盒(免疫比浊法)

规格型号

R1:1×18ml,R2:1×6ml、R1:2×60ml,R2:2×20ml、R1:2×60ml,R2:1×40ml、R1:3×40ml,R2:2×20ml、R1:3×60ml,R2:1×60ml、R1:3×50ml,R2:1×50ml、R1:3×100ml,R2:1×100ml、R1:4×60ml,R2:2×40ml R1:5×60ml,R2:2×50ml、R1:4×40ml,R2:2×40ml、R1:4×40ml,R2:1×40ml、R1:1×3000ml,R2:1×1000ml、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R1: Tris缓冲液、PEG-8000

R2: 抗载脂蛋白E抗体

预期用途

用于体外定量测定人血清中载脂蛋白E的含量。

产品名称

33、β2-微球蛋白测定试剂盒(免疫比浊法)

规格型号

R1:1×24ml,R2:1×6ml、R1:1×60ml,R2:1×15ml、R1:2×60ml,R2:2×15ml、R1:4×50ml,R2:2×25ml、R1:4×60ml,R2:4×15ml、R1:6×40ml,R2:3×20ml、R1:2×100ml,R2:1×50ml、R1:4×60ml,R2:1×60ml、R1:4×60ml,R2:2×30ml、R1:4×50ml,R2:2×35ml、R1:4×50ml,R2:2×50ml、R1:1×4000ml,R2:1×1000ml、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R1: Tris缓冲液、PEG-8000

R2: 乳胶包被抗人β2-微球蛋白抗体

预期用途

用于体外定量测定人血清中β2-微球蛋白的含量。

产品名称

34、胱抑素C测定试剂盒(免疫比浊法)

规格型号

R1:1×24ml,R2:1×6ml、R1:1×60ml,R2:1×15ml、R1:2×60ml,R2:2×15ml、R1:4×50ml,R2:2×25ml、R1:4×60ml,R2:4×15ml、R1:6×40ml,R2:3×20ml、R1:2×100ml,R2:1×50ml、R1:4×60ml,R2:1×60ml R1:4×60ml,R2:2×30ml、R1:4×50ml,R2:2×35ml、R1:4×50ml,R2:2×50ml、R1:1×4000ml,R2:1×1000ml、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R1: Tris 缓冲液、PEG-8000

R2: 乳胶包被抗人胱抑素C抗体

预期用途

用于体外定量测定人血清中胱抑素C的含量。

产品名称

35、视黄醇结合蛋白测定试剂盒(免疫比浊法)

规格型号

R1:1×18ml,R2:1×6ml、R1:1×30ml,R2:1×10ml、R1:2×60ml,R2:1×40ml、R1:3×40ml,R2:2×20ml、R1:3×60ml,R2:1×60ml、R1:3×50ml,R2:1×50ml、R1:3×100ml,R2:1×100ml、R1:4×60ml,R2:2×40ml R1:5×60ml,R2:2×50ml、R1:4×40ml,R2:2×40ml、R1:4×40ml,R2:1×40ml、R1:1×3000ml,R2:1×1000ml、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R1: Tris 缓冲液、PEG-8000

R2: 视黄醇结合蛋白抗体

预期用途

用于体外定量测定人血清中视黄醇结合蛋白的含量。

产品名称

36、D-二聚体测定试剂盒(免疫比浊法)

规格型号

R1:1×18ml,R2:1×6ml、R1:1×30ml,R2:1×10ml、R1:2×60ml,R2:1×40ml、R1:3×40ml,R2:2×20ml、R1:3×60ml,R2:1×60ml、R1:3×50ml,R2:1×50ml、R1:3×100ml,R2:1×100ml、R1:4×60ml,R2:2×40ml、R1:5×60ml,R2:2×50ml、R1:4×40ml,R2:2×40ml、R1:4×40ml,R2:1×40ml、R1:1×3000ml,R2:1×1000ml、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R1: Tris缓冲液、PEG-8000

R2: 乳胶包被抗人D-二聚体抗体

预期用途

用于体外定量测定人血清中D-二聚体的含量。

产品名称

37、肌红蛋白测定试剂盒(免疫比浊法)

规格型号

R1:1×18ml,R2:1×6ml、R1:2×60ml,R2:2×20ml、R1:2×60ml,R2:1×40ml、R1:3×40ml,R2:2×20ml、R1:3×60ml,R2:1×60ml、R1:3×50ml,R2:1×50ml、R1:3×100ml,R2:1×100ml、R1:4×60ml,R2:2×40ml、R1:5×60ml,R2:2×50ml、R1:4×40ml,R2:2×40ml、R1:4×40ml,R2:1×40ml、R1:1×3000ml,R2:1×1000ml、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R1: Tris缓冲液、PEG-8000

R2: 乳胶包被抗人肌红蛋白抗体

预期用途

用于体外定量测定人血清中肌红蛋白的含量。

产品名称

38、类风湿因子测定试剂盒(免疫比浊法)

规格型号

R1:1×24ml,R2:1×6ml、R1:1×60ml,R2:1×15ml、R1:2×60ml,R2:2×15ml、R1:4×50ml,R2:2×25ml、R1:4×60ml,R2:4×15ml、R1:6×40ml,R2:3×20ml、R1:2×100ml,R2:1×50ml、R1:4×60ml,R2:1×60ml、R1:4×60ml,R2:2×30ml、R1:4×50ml,R2:2×35ml、R1:4×50ml,R2:2×50ml、R1:1×4000ml,R2:1×1000ml、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R1: Tris缓冲液、PEG-8000

R2: RF致敏乳胶

预期用途

用于体外定量测定人血清中类风湿因子的含量。

产品名称

39、抗链球菌溶血素“O”测定试剂盒(免疫比浊法)

规格型号

R1:1×24ml,R2:1×6ml、R1:1×60ml,R2:1×15ml、R1:2×60ml,R2:2×15ml、R1:4×50ml,R2:2×25ml、R1:4×60ml,R2:4×15ml、R1:6×40ml,R2:3×20ml、R1:2×100ml,R2:1×50ml、R1:4×60ml,R2:1×60ml、R1:4×60ml,R2:2×30ml、R1:4×50ml,R2:2×35ml、R1:4×50ml,R2:2×50ml、R1:1×4000ml,R2:1×1000ml、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R1: Tris缓冲液、PEG-8000

R2: 包被链球菌溶血素“O” 乳胶

预期用途

用于体外定量测定人血清中抗链球菌溶血素“O”的含量。

产品名称

40、C-反应蛋白测定试剂盒(免疫比浊法)

规格型号

R1:1×24ml,R2:1×6ml、R1:1×60ml,R2:1×15ml、R1:2×60ml,R2:2×15ml、R1:4×50ml,R2:2×25ml、R1:4×60ml,R2:4×15ml、R1:4×60ml,R2:1×60ml、R1:4×40ml,R2:2×20ml、R1:1×4000ml,R2:1×1000ml、R1:2×40ml,R2:2×20ml、R1:2×60ml,R2:2×30ml、R1:4×50ml,R2:2×50ml、R1:4×60ml,R2:2×60ml、R1:5×60ml,R2:3×50ml、R1:2×60ml,R2:2×60ml、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R1: Tris缓冲液、PEG-8000

R2: 乳胶包被抗人C-反应蛋白抗体

预期用途

用于体外定量测定人血清中C-反应蛋白的含量。

产品名称

41、前白蛋白测定试剂盒(免疫比浊法)

规格型号

R1:1×18ml,R2:1×6ml、R1:2×60ml,R2:2×20ml、R1:2×60ml,R2:1×40ml、R1:3×40ml,R2:2×20ml、R1:3×60ml,R2:1×60ml、R1:3×50ml,R2:1×50ml、R1:3×100ml,R2:1×100ml、R1:4×60ml,R2:2×40ml、R1:5×60ml,R2:2×50ml、R1:4×40ml,R2:2×40ml、R1:4×40ml,R2:1×40ml、R1:1×3000ml,R2:1×1000ml、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R1: Tris缓冲液、PEG-8000

R2: 抗前白蛋白抗体

预期用途

用于体外定量测定人血清中前白蛋白的含量。

产品名称

42、总胆红素测定试剂盒(氧化法)

规格型号

R1:1×40ml,R2:1×10ml、R1:1×60ml,R2:1×15ml、R1:2×60ml,R2:2×15ml、R1:4×50ml,R2:2×25ml、R1:4×60ml,R2:4×15ml、R1:6×40ml,R2:3×20ml、R1:2×100ml,R2:1×50ml、R1:4×60ml,R2:1×60ml、R1:4×60ml,R2:2×30ml、R1:4×50ml,R2:2×35ml、R1:4×50ml,R2:2×50ml、R1:1×4000ml,R2:1×1000ml、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R1: 枸橼酸缓冲液、表面活性剂

R2: 磷酸盐缓冲液、亚硝酸钠

预期用途

用于体外定量测定人血清中总胆红素的含量。

产品名称

43、直接胆红素测定试剂盒(氧化法)

规格型号

R1:1×40ml,R2:1×10ml、R1:1×60ml,R2:1×15ml、R1:2×60ml,R2:2×15ml、R1:4×50ml,R2:2×25ml、R1:4×60ml,R2:4×15ml、R1:6×40ml,R2:3×20ml、R1:2×100ml,R2:1×50ml、R1:4×60ml,R2:1×60ml、R1:4×60ml,R2:2×30ml、R1:4×50ml,R2:2×35ml、R1:4×50ml,R2:2×50ml、R1:1×4000ml,R2:1×1000ml、12×60Ts、注:特殊规格根据临床需求提供。

主要组成成份

R1: 酒石酸缓冲液、表面活性剂

R2: 磷酸盐缓冲液、亚硝酸钠

预期用途

用于体外定量测定人血清中直接胆红素的含量。

 

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