China NMPA legacy archive 京械注准20242400729

Alanine aminotransferase assay kit (alanine substrate method)

Name: Alanine aminotransferase assay kit (alanine substrate method) — NMPA archive 京械注准20242400729
Creator: Beijing Strong Biotechnologies,Inc.
Keywords: Alanine aminotransferase assay kit (alanine substrate method), 丙氨酸氨基转移酶测定试剂盒（丙氨酸底物法）, 京械注准20242400729, Class II, NMPA registration

丙氨酸氨基转移酶测定试剂盒（丙氨酸底物法）

Beijing Strong Biotechnologies,Inc.Class IINMPAApproved November 26, 2024

Static archiveNMPA · legacy registration snapshot

Device classification

Device class: Class II
Model specifications: 试剂1:2;55mL、试剂2:2;18mL;试剂1:2;51mL、试剂2:2;17mL;892测试/盒;830测试/盒.
Approval department: Beijing Municipal Drug Administration

Registration information

Registration number: 京械注准20242400729
Approval date: November 26, 2024
Expiry date: November 25, 2029

Registrant

Name: Beijing Strong Biotechnologies,Inc.
Province/Region: Beijing
Address: 5th floor, Kuanyi Building, No. 15 Huayuan East Road, Haidian District, Beijing

Production facility

Production address: 北京市怀柔区雁栖经济开发区雁栖北二街15号

Intended use

English

本试剂盒用于体外定量测定人血清中丙氨酸氨基转移酶(谷丙转氨酶,ALT)含量.

中文

本试剂盒用于体外定量测定人血清中丙氨酸氨基转移酶（谷丙转氨酶，ALT）含量。

Structure and composition

English

试剂成分浓度试剂1:Goodrsquo;s缓冲液,pH9.0L-丙氨酸还原型辅酶I乳酸脱氢酶20mmol/L100mmol/L0.43mmol/L5KU/L试剂2:alpha;-酮戊二酸45mmol/L

中文

试剂成分浓度试剂1：Goodrsquo;s缓冲液，pH9.0L-丙氨酸还原型辅酶I乳酸脱氢酶20mmol/L100mmol/L0.43mmol/L5KU/L试剂2：alpha;-酮戊二酸45mmol/L

Storage conditions and expiration

English

试剂盒在2℃~ 8℃密封避光保存,有效期12个月.

中文

试剂盒在2℃~ 8℃密封避光保存，有效期12个月。

About this record

This static archive preserves historical registration fields and translations for Alanine aminotransferase assay kit (alanine substrate method), registration 京械注准20242400729. It does not establish current authorization or complete current product details.

The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.