序號?
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企業(yè)名稱?
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產(chǎn)品名稱?
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規(guī)格/型號?
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主要結(jié)構(gòu)組成?
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產(chǎn)品適用范圍?
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注冊形式?
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1?
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長春市曼特諾醫(yī)療器械有限公司?
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直接膽紅素測定試劑盒(重氮鹽法)?
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R1:100ml×4? R2:20ml×4? R1:100ml×2? R2:20ml×2?? R1:100ml×1? R2:20ml×1?
R1:80ml×4?? R2:16ml×4? R1:80ml×2?? R2:16ml×2?? R1:80ml×1?? R2:16ml×1?
R1:60ml×4?? R2:12ml×4? R1:60ml×2?? R2:12ml×2?? R1:60ml×1?? R2:12ml×1?
R1:40ml×4?? R2:8ml×4?? R1:40ml×2?? R2:8ml×2??? R1:40ml×1?? R2:8ml×1 ?
R1:35ml×4?? R2:7ml×4?? R1:35ml×2?? R2:7ml×2??? R1:35ml×1?? R2:7ml×1 ?
R1:20ml×4?? R2:4ml×4?? R1:20ml×2?? R2:4ml×2??? R1:20ml×1?? R2:4ml×1?
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??
組成?
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成分?
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濃度?
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試劑1?
(R1)?
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對氨基苯磺酸?
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29mmol/L?
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濃鹽酸?
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0.15%(V/V)?
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試劑2?
(R2)?
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亞硝酸鈉?
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1.05mmol/L?
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本試劑盒用于體外定量測定人血清中直接膽紅素的含量。?
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延續(xù)注冊?
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2?
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長春市曼特諾醫(yī)療器械有限公司?
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甘油三酯測定試劑盒(GPO-PAP法)?
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R1:100ml×4? R2:25ml×4? R1:100ml×2? R2:25ml×2? R1:100ml×1? R2:25ml×1?
R1:80ml×4?? R2:20ml×4? R1:80ml×2?? R2:20ml×2? R1:80ml×1?? R2:20ml×1?
R1:60ml×4?? R2:15ml×4? R1:60ml×2?? R2:15ml×2? R1:60ml×1?? R2:15ml×1?
R1:40ml×4?? R2:10ml×4? R1:40ml×2?? R2:10ml×2? R1:40ml×1?? R2:10ml×1?
R1:32ml×4?? R2:8ml×4?? R1:32ml×2?? R2:8ml×2?? R1:32ml×1?? R2:8ml×1?
R1:20ml×4?? R2:5ml×4?? R1:20ml×2?? R2:5ml×2?? R1:20ml×1?? R2:5ml×1?
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組成?
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成分?
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濃度?
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試劑1?
(R1)?
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Tris緩沖液?
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100mmol/L?
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DHBS?
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1.8mmol/L?
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ATP·Na2?
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1mmol/L?
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過氧化物酶?
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2500U/L?
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磷酸甘油氧化酶?
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5000U/L?
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試劑2?
(R2)?
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Tris緩沖液?
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100mmol/L?
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4-氨基安替比林?
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2.5mmol/L?
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甘油激酶?
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2500U/L?
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脂蛋白酯酶?
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2000kU/L?
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??
??
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本試劑盒用于體外定量測定人血清中甘油三酯的含量。?
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延續(xù)注冊?
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3?
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長春市曼特諾醫(yī)療器械有限公司?
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尿酸測定試劑盒(尿酸酶法)?
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R1:100ml×4? R2:25ml×4;R1:100ml×2? R2:25ml×2; R1:100ml×1? R2:25ml×1;?
R1:80ml×4?? R2:20ml×4;R1:80ml×2?? R2:20ml×2; R1:80ml×1?? R2:20ml×1;?
R1:60ml×4?? R2:15ml×4;R1:60ml×2?? R2:15ml×2; R1:60ml×1?? R2:15ml×1;?
R1:40ml×4?? R2:10ml×4;R1:40ml×2?? R2:10ml×2; R1:40ml×1?? R2:10ml×1;?
R1:32ml×4?? R2:8ml×4; R1:32ml×2?? R2:8ml×2;? R1:32ml×1?? R2:8ml×1;?
R1:20ml×4?? R2:5ml×4; R1:20ml×2?? R2:5ml×2;? R1:20ml×1?? R2:5ml×1;?
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??
組成?
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成分?
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濃度?
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試劑1?
(R1)?
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磷酸鹽緩沖液?
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68mmol/L?
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過氧化物酶?
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2500U/L?
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DHBS?
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1.8mmol/L?
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試劑2?
(R2)?
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磷酸鹽緩沖液?
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68mmol/L?
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4-氨基安替比林?
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2.5mmol/L?
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尿酸酶?
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1500U/L?
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本試劑盒用于體外定量測定人血清中尿酸的含量。本試劑盒用于體外定量測定人血清中尿酸的含量。?
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延續(xù)注冊?
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4?
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長春市曼特諾醫(yī)療器械有限公司?
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尿素測定試劑盒(尿素酶-谷氨酸脫氫酶法)?
|
R1:100ml×4? R2:25ml×4; R1:100ml×2? R2:25ml×2;? R1:100ml×1? R2:25ml×1;?
R1:80 ml×4? R2:20ml×4; R1:80 ml×2? R2:20ml×2;? R1:80 ml×1? R2:20ml×1;?
R1:60ml×4?? R2:15ml×4; R1:60ml×2?? R2:15ml×2;? R1:60ml×1?? R2:15ml×1;?
R1:40ml×4?? R2:10ml×4; R1:40ml×2?? R2:10ml×2;? R1:40ml×1?? R2:10ml×1;?
R1:32ml×4?? R2:8ml×4;? R1:32ml×2?? R2:8ml×2;?? R1:32ml×1?? R2:8ml×1;?
R1:20ml×4?? R2:5ml×4;? R1:20ml×2?? R2:5ml×2 ;? R1:20ml×1?? R2:5ml×1 ?
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??
組成?
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成分?
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濃度?
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試劑1?
(R1)?
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Tris緩沖液?
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100mmol/L?
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二磷酸腺苷?
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0.7mmol/L?
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還原性輔酶1?
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10000U/L?
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谷氨酸脫氫酶?
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1000U/L?
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試劑2?
(R2)?
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Tris緩沖液?
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100mmol/L?
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α-酮戊二酸?
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80mmol/L?
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脲酶?
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1.1mmol/L?
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本試劑盒用于體外定量測定人血清中尿素的含量。?
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延續(xù)注冊?
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5?
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長春市曼特諾醫(yī)療器械有限公司?
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肌酐測定試劑盒(苦味酸法)?
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R1:100ml×4? R2:25ml×4; R1:100ml×2? R2:25ml×2; R1:100ml×1? R2:25ml×1;?
R1:80ml×4?? R2:20ml×4; R1:80ml×2?? R2:20ml×2; R1:80ml×1?? R2:20ml×1;?
R1:60ml×4?? R2:15ml×4; R1:60ml×2?? R2:15ml×2; R1:60ml×1?? R2:15ml×1;?
R1:40ml×4?? R2:10ml×4; R1:40ml×2?? R2:10ml×2; R1:40ml×1?? R2:10ml×1;?
R1:32ml×4?? R2:8ml×4;? R1:32ml×2?? R2:8ml×2;? R1:32ml×1?? R2:8ml×1;?
R1:20ml×4?? R2:5ml×4;? R1:20ml×2?? R2:5ml×2;? R1:20ml×1?? R2:5ml×1?
|
??
組成?
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成分?
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含量?
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試劑1?
(R1)?
|
氫氧化鈉(NaOH)?
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350mmol/L?
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試劑2?
(R2)?
|
苦味酸?
|
35mmol/L?
|
|
本試劑盒用于體外定量測定人血清中肌酐的含量。?
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延續(xù)注冊?
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6?
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長春市曼特諾醫(yī)療器械有限公司?
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低密度脂蛋白膽固醇測定試劑盒(直接法-表面活性劑清除法)?
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R1:100ml×4? R2:25ml×4; R1:100ml×2? R2:25ml×2; R1:100ml×1? R2:25ml×1;?
R1:80ml×4?? R2:20ml×4; R1:80ml×2?? R2:20ml×2; R1:80ml×1?? R2:20ml×1;?
R1:60ml×4?? R2:15ml×4; R1:60ml×2?? R2:15ml×2; R1:60ml×1?? R2:15ml×1; ?
R1:40ml×4?? R2:10ml×4; R1:40ml×2?? R2:10ml×2; R1:40ml×1?? R2:10ml×1;?
R1:32ml×4?? R2:8ml×4;? R1:32ml×2?? R2:8ml×2;? R1:32ml×1?? R2:8ml×1;?
R1:20ml×4?? R2:5ml×4;? R1:20ml×2?? R2:5ml×2;? R1:20ml×1?? R2:5ml×1;?
|
??
組成?
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名稱?
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含量?
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試劑1?
(R1)?
|
1,4-哌嗪二乙磺酸倍半鈉(PIPES緩沖液)?
|
50mmol/L?
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4-氨基安替比林(4-AA)?
|
5mmol/L?
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膽固醇氧化酶?
|
800U/L?
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膽固醇脂酶?
|
400U/L?
|
過氧化物酶?
|
3kU/L?
|
試劑2?
(R2)?
|
1,4-哌嗪二乙磺酸倍半鈉(PIPES緩沖液)?
|
50mmol/L?
|
N-乙基-間甲基苯胺-2-羥丙基磺酸鈉(TOOS)?
|
2mmol/L?
|
抗壞血酸氧化酶?
|
100U/L?
|
Triton X-100?
|
3%(V/V)?
|
|
本試劑盒用于體外定量測定人血清中低密度脂蛋白膽固醇的含量。?
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延續(xù)注冊?
|
7?
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長春市曼特諾醫(yī)療器械有限公司?
|
前白蛋白測定試劑盒(免疫比濁法)?
|
R:100ml×4;R:100ml×2;????? R:100ml×1;R:80ml×4;????? R:80ml×2;R:80ml×1;?
R:60ml×4;R:60ml×2;?????? R:60ml×1;R:50ml×4;????? R:50ml×2;R:50ml×1;?
R:40ml×4;R:40ml×2;?????? R:40ml×1;R:30ml×4;????? R:30ml×2;R:30ml×1;?
R:20ml×4;R:20ml×2;?????? R:20ml×1;?
|
??
Tris-HCl 磷酸緩沖液?
|
100mmol/L?
|
羊抗人前白蛋白人抗血清?
|
1:70?
|
迭氮化鈉?
|
0.5g/l?
|
|
本試劑盒用于體外定量測定人血清中前白蛋白的含量。?
|
延續(xù)注冊?
|
8?
|
長春市曼特諾醫(yī)療器械有限公司?
|
堿性磷酸酶測定試劑盒(NPP底物-AMP緩沖液法)?
|
R1:100ml×4? R2:25ml×4?? R1:100ml×2? R2:25ml×2?? R1:100ml×1? R2:25ml×1?
R1:80ml×4?? R2:20ml×4?? R1:80ml×2?? R2:20ml×2?? R1:80ml×1?? R2:20ml×1?
R1:60ml×4?? R2:15ml×4?? R1:60ml×2?? R2:15ml×2?? R1:60ml×1?? R2:15ml×1?
R1:40ml×4?? R2:10ml×4?? R1:40ml×2?? R2:10ml×2?? R1:40ml×1?? R2:10ml×1?
R1:32ml×4?? R2:8ml×4??? R1:32ml×2?? R2:8ml×2??? R1:32ml×1?? R2:8ml×1?
R1:20ml×4?? R2:5ml×4??? R1:20ml×2?? R2:5ml×2??? R1:20ml×1?? R2:5ml×1?
|
??
組成?
|
成分?
|
濃度?
|
試劑1?
(R1)?
|
AMP?
|
350mmol/L?
|
試劑2?
(R2)?
|
磷酸對硝基酚二鈉?
|
22mmol/L?
|
|
本試劑盒用于體外定量測定人血清中堿性磷酸酶的含量。?
|
延續(xù)注冊?
|
9?
|
長春市曼特諾醫(yī)療器械有限公司?
|
乳酸脫氫酶測定試劑盒(乳酸底物法)?
|
R1:100ml×4? R2:25ml×4?? R1:100ml×2? R2:25ml×2?? R1:100ml×1? R2:25ml×1?
R1:80ml×4?? R2:20ml×4 ??R1:80ml×2?? R2:20ml×2?? R1:80ml×1?? R2:20ml×1?
R1:60ml×4?? R2:15ml×4?? R1:60ml×2?? R2:15ml×2?? R1:60ml×1?? R2:15ml×1?
R1:40ml×4?? R2:10ml×4?? R1:40ml×2?? R2:10ml×2?? R1:40ml×1?? R2:10ml×1?
R1:32ml×4?? R2:8ml×4??? R1:32ml×2?? R2:8ml×2?? R1:32ml×1?? R2:8ml×1?
R1:20ml×4?? R2:5ml×4??? R1:20ml×2?? R2:5ml×2?? R1:20ml×1?? R2:5ml×1?
|
??
組成?
|
名稱?
|
?含量?
|
試劑1?
(R1)?
|
Tris緩沖液?
|
100mmol/L?
|
L-乳酸鋰(L-Lactic acid,lithium salt)?
|
68.5mmol/L?
|
試劑2?
(R2)?
|
Tris緩沖液?
|
100mmol/L?
|
氧化型輔酶I(NAD+)?
|
15mmol/L?
|
|
本試劑盒用于體外定量測定人血清中乳酸脫氫酶的含量。?
|
延續(xù)注冊?
|
10?
|
長春市曼特諾醫(yī)療器械有限公司?
|
葡萄糖測定試劑盒(葡萄糖氧化酶法)?
|
R1:100ml×4? R2:25ml×4; R1:100ml×2? R2:25ml×2;? R1:100ml×1? R2:25ml×1;?
R1:80ml×4?? R2:20ml×4; R1:80ml×2?? R2:20ml×2;? R1:80ml×1?? R2:20ml×1;?
R1:60ml×4?? R2:15ml×4; R1:60ml×2?? R2:15ml×2;? R1:60ml×1?? R2:15ml×1;?
R1:40ml×4?? R2:10ml×4; R1:40ml×2?? R2:10ml×2;? R1:40ml×1?? R2:10ml×1;?
R1:32ml×4?? R2:8ml×4;? R1:32ml×2?? R2:8ml×2;?? R1:32ml×1?? R2:8ml×1;?
R1:20ml×4?? R2:5ml×4;? R1:20ml×2?? R2:5ml×2;?? R1:20ml×1?? R2:5ml×1;?
|
??
組成?
|
成分?
|
濃度?
|
試劑1?
(R1)?
|
PIPES緩沖液?
|
40mmol/L?
|
4-氨基安替比林?
|
0.7mmol/L?
|
葡萄糖氧化酶?
|
7000U/L?
|
試劑2?
(R2)?
|
PIPES緩沖液?
|
40mmol/L?
|
對羥基苯甲酸鈉?
|
125mmol/L?
|
過氧化物酶?
|
25000U/L?
|
|
本試劑盒用于體外定量測定人血清中葡萄糖的含量。?
|
延續(xù)注冊?
|
11?
|
長春市曼特諾醫(yī)療器械有限公司?
|
總膽汁酸測定試劑盒(酶循環(huán)法)?
|
R1:90ml×4? R2:30ml×4 R1:90ml×2? R2:30ml×2? R1:90ml×1?? R2:30ml×1 ?
R1:60ml×4? R2:20ml×4 R1:60ml×2? R2:20ml×2? R1:60ml×1?? R2:20ml×1?
R1:48ml×4? R2:16ml×4 R1:48ml×2? R2:16ml×2? R1:48ml×1?? R2:16ml×1 ?
R1:30ml×4? R2:10ml×4 R1:30ml×2? R2:10ml×2? R1:30ml×1?? R2:10ml×1?
R1:18ml×4? R2: 6ml×4 R1:18ml×2? R2: 6ml×2? R1:18ml×1?? R2: 6ml×1?
|
??
組成?
|
成分?
|
濃度?
|
試劑1?
(R1)?
|
1,4-哌嗪二乙磺酸倍半鈉(PIPES緩沖液)?
|
50mmol/L?
|
硫代氧化型輔酶I?
|
2mmol/L?
|
試劑2?
(R2)?
|
三羥基氨基甲烷(Tris緩沖液)?
|
50mmol/L?
|
還原型輔酶I二鈉(NADH·Na2)?
|
2.5mmol/L?
|
3α-羥類固醇脫氫酶?
|
30kU/L?
|
|
本試劑盒用于體外定量測定人血清中總膽汁酸的含量。?
|
延續(xù)注冊?
|
12?
|
長春市曼特諾醫(yī)療器械有限公司?
|
總蛋白測定試劑盒(雙縮脲法)?
|
R:100ml×4 R:100ml×2?????? R:100ml×1R:80ml×4?????? R:80ml×2R:80ml×1?
R:60ml×4 R:60ml×2??????? R:60ml×1R:40ml×4?????? R:40ml×2 R:40ml×1?
R:25ml×4 R:25ml×2??????? R:25ml×1R:20ml×4?????? R:20ml×2 R:20ml×1?
|
??
組成?
|
成分?
|
濃度?
|
試劑?
(R)?
|
硫酸銅?
|
18.8mmol/L?
|
酒石酸鉀鈉?
|
31.9mmol/L?
|
碘化鉀?
|
18.1mmol/L?
|
|
本試劑盒用于體外定量測定人血清中總蛋白的含量。?
|
延續(xù)注冊?
|
13?
|
長春市曼特諾醫(yī)療器械有限公司?
|
天門冬氨酸氨基轉(zhuǎn)移酶測定試劑盒(天門冬氨酸底物法)?
|
R1:100ml×4? R2:25ml×4?? R1:100ml×2? R2:25ml×2? R1:100ml×1? R2:25ml×1?
R1:80ml×4?? R2:20ml×4?? R1:80ml×2?? R2:20ml×2? R1:80ml×1?? R2:20ml×1?
R1:60ml×4?? R2:15ml×4?? R1:60ml×2?? R2:15ml×2? R1:60ml×1?? R2:15ml×1?
R1:40ml×4?? R2:10ml×4?? R1:40ml×2?? R2:10ml×2? R1:40ml×1?? R2:10ml×1?
R1:32ml×4?? R2:8ml×4??? R1:32ml×2?? R2:8ml×2?? R1:32ml×1?? R2:8ml×1?
R1:20ml×4?? R2:5ml×4??? R1:20ml×2?? R2:5ml×2?? R1:20ml×1?? R2:5ml×1 ?
|
??
組成?
|
成分?
|
濃度?
|
試劑1?
(R1)?
|
Tris緩沖液?
|
100mmol/L?
|
L-天冬氨酸?
|
280mmol/L?
|
乳酸脫氫酶?
|
1000U/L?
|
蘋果酸脫氫酶?
|
1200U/L?
|
試劑2?
(R2)?
|
Tris緩沖液?
|
100mmol/L?
|
α-酮戊二酸?
|
80mmol/L?
|
還原性輔酶1?
|
1.2mmol/L?
|
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本試劑盒用于體外定量測定人血清中天門冬氨酸氨基轉(zhuǎn)移酶的含量。?
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延續(xù)注冊?
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14?
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長春市曼特諾醫(yī)療器械有限公司?
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α-羥丁酸脫氫酶測定試劑盒(α-酮丁酸底物法)?
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R1:100ml×4? R2:25ml×4;? R1:100ml×2?? R2:25ml×2;? R1:100ml×1? R2:25ml×1;?
R1:80ml×4?? R2:20ml×4;? R1:80ml×2??? R2:20ml×2;? R1:80ml×1?? R2:20ml×1;?
R1:60ml×4?? R2:15ml×4;? R1:60ml×2??? R2:15ml×2;? R1:60ml×1?? R2:15ml×1;?
R1:40ml×4?? R2:10ml×4;? R1:40ml×2??? R2:10ml×2;? R1:40ml×1?? R2:10ml×1;?
R1:32ml×4?? R2:8ml×4;?? R1:32ml×2??? R2:8ml×2;?? R1:32ml×1?? R2:8ml×1;?
R1:20ml×4?? R2:5ml×4;?? R1:20ml×2??? R2:5ml×2;?? R1:20ml×1?? R2:5ml×1; ?
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??
組成?
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成分?
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濃度?
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試劑1?
(R1)?
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Tris緩沖液?
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100mmol/L?
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α-氧代丁酸?
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3.5mmol/L?
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試劑2?
(R2)?
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Tris緩沖液?
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100mmol/L?
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NADH?
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1mmol/L?
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本試劑盒用于體外定量測定人血清中α-羥丁酸脫氫酶的含量。?
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延續(xù)注冊?
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15?
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長春市曼特諾醫(yī)療器械有限公司?
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γ-谷氨?;D(zhuǎn)移酶測定試劑盒(GCANA底物法)?
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R1:100ml×4? R2:25ml×4?? R1:100ml×2? R2:25ml×2?? R1:100ml×1? R2:25ml×1?
R1:80ml×4?? R2:20ml×4?? R1:80ml×2?? R2:20ml×2?? R1:80ml×1?? R2:20ml×1?
R1:60ml×4?? R2:15ml×4?? R1:60ml×2?? R2:15ml×2?? R1:60ml×1?? R2:15ml×1?
R1:40ml×4?? R2:10ml×4?? R1:40ml×2?? R2:10ml×2?? R1:40ml×1?? R2:10ml×1?
R1:32ml×4?? R2:8ml×4??? R1:32ml×2?? R2:8ml×2??? R1:32ml×1?? R2:8ml×1?
R1:20ml×4?? R2:5ml×4??? R1:20ml×2?? R2:5ml×2??? R1:20ml×1?? R2:5ml×1?
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??
組成?
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成分?
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濃度?
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試劑1?
(R1)?
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Tris緩沖液?
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100mmol/L?
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雙甘肽?
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100mmol/L?
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試劑2?
(R2)?
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L-γ-谷氨酰-3-羧基-4-硝基苯胺?
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12.5mmol/L?
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本試劑盒用于體外定量測定人血清中谷氨?;D(zhuǎn)移酶的含量。?
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延續(xù)注冊?
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16?
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吉林雙正醫(yī)療科技有限公司?
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精子SP10蛋白檢測試紙(膠體金法)?
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卡型(1人份/袋)1人份/盒、2人份/盒、5人份/盒、10人份/盒、25人份/盒、30人份/盒、40人份/盒、50人份/盒。?
條型(1人份/袋)1人份/盒、2人份/盒、5人份/盒、10人份/盒、25人份/盒、30人份/盒、40人份/盒、50人份/盒。?
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1.檢測卡。檢測卡由塑料板卡、檢測條組成;檢測條由硝酸纖維素膜(內(nèi)含鼠抗人SP10抗體2和羊抗鼠IgG抗體)、吸水紙、載樣墊和載金墊(內(nèi)含膠體金,鼠抗人SP10抗體1組成。?稀釋液:磷酸鹽緩沖液PBS:(0.lM,pH7.4),1% Tween-20。?取樣杯、精液轉(zhuǎn)移器、收集管(含2mL稀釋液)。?
2.
3.
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產(chǎn)品用于體外定性檢測人精液中的精子SP10蛋白。?
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首次注冊?
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