China NMPA legacy archive 京械注准20242400684氨测定试剂盒(谷氨酸脱氢酶法)
- Device class
- Class II
- Model specifications
- 试剂1:2;54mL、试剂2:2;22mL;试剂1:2;52mL、试剂2:2;21mL;840测试/盒;810测试/盒;校准品(单水平):1;1mL;质控品(水平1):1;1mL;质控品(水平2):1;1mL.
- Approval department
- Beijing Municipal Drug Administration
- Registration number
- 京械注准20242400684
- Approval date
- November 12, 2024
- Expiry date
- November 11, 2029
- Province/Region
- Beijing
- Address
- 5th floor, Kuanyi Building, No. 15 Huayuan East Road, Haidian District, Beijing
- Production address
- 北京市怀柔区雁栖经济开发区雁栖北二街15号
This kit is used for the in vitro quantitative determination of ammonia (AMM) content in human plasma.
本试剂盒用于体外定量测定人血浆中氨（AMM）的含量。
试剂成分浓度试剂1:还原型烟酰胺腺嘌呤二核苷酸磷酸alpha;-酮戊二酸0.28mmol/L10mmol/L试剂2:谷氨酸脱氢酶13KU/L校准品(液体,单水平):Goodrsquo;s缓冲液氯化铵100mmol/L单水平:200-400mu;mol/L质控品(液体,2水平):Goodrsquo;s缓冲液氯化铵100mmol/L水平1:50-250mu;mol/L水平2:280-500mu;mol/L
试剂成分浓度试剂1：还原型烟酰胺腺嘌呤二核苷酸磷酸alpha;-酮戊二酸0.28mmol/L10mmol/L试剂2：谷氨酸脱氢酶13KU/L校准品（液体，单水平）：Goodrsquo;s缓冲液氯化铵100mmol/L单水平：200-400mu;mol/L质控品（液体，2水平）：Goodrsquo;s缓冲液氯化铵100mmol/L水平1：50-250mu;mol/L水平2：280-500mu;mol/L
试剂盒在2℃~ 8℃密封避光保存,有效期12个月.
试剂盒在2℃~ 8℃密封避光保存，有效期12个月。
This static archive preserves historical registration fields and translations for 氨测定试剂盒(谷氨酸脱氢酶法), registration 京械注准20242400684. It does not establish current authorization or complete current product details.
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