α-Amylase (α-AMY) detection reagent kit (EPS substrate method) - NMPA Registration 京械注准20222400292

Access comprehensive regulatory information for α-Amylase (α-AMY) detection reagent kit (EPS substrate method) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 京械注准20222400292 and owned by Beijing Baiao Taikang Biotechnology Co., Ltd.. The device was approved on July 22, 2022.

This page provides complete registration details including registrant information, province location (Beijing), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.

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NMPA Official Data

Class II

京械注准20222400292

α-Amylase (α-AMY) detection reagent kit (EPS substrate method)

α-淀粉酶(α-AMY)测定试剂盒(EPS底物法)

NMPA Registration Number: 京械注准20222400292

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Intended Use

English

For in vitro quantitative determination of α-amylase activity in human serum or urine.

中文

用于体外定量测定人血清或尿液中α-淀粉酶的活性。

Device Classification

Device Class

Class II

Model Specifications

Reagent 1: 90mL×4, Reagent 2: 90mL×1; Reagent 1: 90mL×5, Reagent 2: 90mL×1; Reagent 1: 90mL×4, Reagent 2: 45mL×2; Reagent 1: 60mL×5, Reagent 2: 12mL×5; Reagent 1: 60mL×5, Reagent 2: 15mL×5; Reagent 1: 90mL×5, Reagent 2: 45mL×2; Reagent 1: 60mL×2, Reagent 2: 15mL×2; Reagent 1: 60mL×2, Reagent 2: 12mL×2; Reagent 1: 60mL×1, Reagent 2: 15mL×1; Reagent 1: 60mL×1, Reagent 2: 12mL×1; Reagent 1: 60mL×4, Reagent 2: 60mL×1; Reagent 1: 60mL×5, Reagent 2: 60mL×1; Reagent 1: 60mL×4, Reagent 2: 30mL×2; Reagent 1: 60mL×5, Reagent 2: 30mL×2; Reagent 1: 40mL × 2, Reagent 2: 10mL×2; Reagent 1: 20mL×1, Reagent 2: 4mL×1; Reagent 1: 40mL×1, Reagent 2: 10mL×1; Reagent 1: 300mL×1, Reagent 2: 60mL×1; Reagent 1: 16mL×1, Reagent 2: 4mL×1; Reagent 1: 5000mL×1, Reagent 2: 1000mL×1; Reagent 1: 280mL×1, Reagent 2: 70mL×1; Reagent 1: 4000mL×1, Reagent 2: 1000mL&

试剂1:90mL×4，试剂2:90mL×1；试剂1:90mL×5，试剂2:90mL×1；试剂1:90mL×4，试剂2:45mL×2；试剂1:60mL×5，试剂2:12mL×5；试剂1:60mL×5，试剂2:15mL×5；试剂1:90mL×5，试剂2:45mL×2；试剂1:60mL×2，试剂2:15mL×2；试剂1:60mL×2，试剂2:12mL×2；试剂1:60mL×1，试剂2:15mL×1；试剂1:60mL×1，试剂2:12mL×1；试剂1:60mL×4，试剂2:60mL×1；试剂1:60mL×5，试剂2:60mL×1；试剂1:60mL×4，试剂2:30mL×2；试剂1:60mL×5，试剂2:30mL×2；试剂1:40mL×2，试剂2:10mL×2；试剂1:20mL×1，试剂2:4mL×1；试剂1:40mL×1，试剂2:10mL×1；试剂1:300mL×1，试剂2:60mL×1；试剂1:16mL×1，试剂2:4mL×1；试剂1:5000mL×1，试剂2:1000mL×1；试剂1:280mL×1，试剂2:70mL×1；试剂1:4000mL×1，试剂2:1000mL&

Approval Department

Beijing Municipal Drug Administration

北京市药品监督管理局

Registration Information

Registration Number

京械注准20222400292

Approval Date

July 22, 2022

Expiry Date

July 21, 2027

Registrant

Name

Beijing Baiao Taikang Biotechnology Co., Ltd.

北京安图生物工程有限公司

Province/Region

Beijing

北京

Address

Building 17 and Building 18, No. 13 Mintai Road, Beiwu Town, Shunyi District, Beijing (Science and Technology Innovation Functional Area)

北京市顺义区北务镇民泰路13号院17号楼、18号楼(科技创新功能区)

Production Facility

Production Address

北京市顺义区北务镇民泰路13号院17号楼、18号楼、24号楼（科技创新功能区）

Structure and Composition

English

Composition Concentration Reagent 1 R1 Good's buffer (pH6-8) (20-200) mmol/L Reagent 2 R2 Good's buffer (pH6-8) 4, 6-Ethylene(G1)-4-nitrobenzene(G7)-α-(1->4)-D-maltoheptose (20-200)mmol/L ≥5g/L

中文

成分浓度试剂1 R1 Good's缓冲液(pH6-8） (20-200)mmol/L 试剂2 R2 Good's缓冲液(pH6-8） 4,6-亚乙基(G1)-4-硝基苯(G7)-α-(1->4)-D-麦芽七糖 (20-200)mmol/L ≥5g/L

Storage Conditions and Expiration

English

2 °C ~ 8 °C sealed storage, the validity period is 18 months

中文

2℃～8℃避光密封贮存，有效期为18个月

Additional Information

Appendix

产品技术要求