Glutathione Reductase Determination Kit (Ultraviolet Enzyme Method) - NMPA Registration 沪械注准20232400081

Access comprehensive regulatory information for Glutathione Reductase Determination Kit (Ultraviolet Enzyme 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 沪械注准20232400081 and owned by Shanghai Fosun LONG March MEDICAL Science Co., Ltd.. The device was approved on April 07, 2023.

This page provides complete registration details including registrant information, province location (Shanghai), 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

沪械注准20232400081

Glutathione Reductase Determination Kit (Ultraviolet Enzyme Method)

谷胱甘肽还原酶测定试剂盒（紫外酶法）

NMPA Registration Number: 沪械注准20232400081

DJ Fang

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Intended Use

English

It is used by medical institutions for the in vitro quantitative detection of glutathione reductase (GR) activity in human serum or plasma samples for auxiliary diagnosis.

中文

供医疗机构用于对人血清或血浆样本中谷胱甘肽还原酶（GR）活性的体外定量检测，作辅助诊断用。

Device Classification

Device Class

Class II

Model Specifications

Reagent 1(R1): 1×25mL, Reagent 2(R2): 1×5mL; Reagent 1(R1): 1×40mL, Reagent 2(R2): 1×8mL; Reagent 1(R1): 2×40mL, Reagent 2(R2): 2×8mL; Reagent 1(R1): 1×50mL, Reagent 2(R2): 1×10mL; Reagent 1(R1): 2×50mL, Reagent 2(R2): 2×10mL; Reagent 1 (R1): 2×50mL, Reagent 2(R2): 1×20mL; Reagent 1(R1): 4×50mL, Reagent 2(R2): 4×10mL; Reagent 1(R1): 4×50mL, Reagent 2(R2): 2×20mL; Reagent 1(R1): 2×60mL, Reagent 2(R2): 2×12mL; Reagent 1(R1): 3×60mL, Reagent 2(R2): 1×36mL; Reagent 1(R1): 2×48mL, Reagent 2(R2): 2×17mL; Reagent 1(R1): 4×48mL, Reagent 2(R2): 4×17mL; Reagent 1(R1): 2×37mL, Reagent 2(R2): 2×11mL; Reagent 1(R1): 4×37mL, Reagent 2(R2): 4×11mL; 2×440 test (for Atellica, ADVIA XPT); 4×440 test (for Atellica, ADVIA XPT); 4×300 test (for Roche COBAS 8000 C701, COBAS 8000 C702); 2×200 test (for Roche Cobas 8000 C701, COBAS 8000 C702); 2×300 TEST (FOR HITACHI LABOSPECT 008 AS); 4×400 TEST (FOR HITACHI LABOSPECT 008 AS); 1×250 test (for F-C800p); 2×250 test (for F-C800p); 4×250 test (for F-C800p); Calibrator (optional): 1×1mL; Quality control (optional): 1×1mL.

试剂1（R1）：1×25mL，试剂2（R2）：1×5mL；试剂1（R1）：1×40mL，试剂2（R2）：1×8mL；试剂1（R1）：2×40mL，试剂2（R2）：2×8mL；试剂1（R1）：1×50mL，试剂2（R2）：1×10mL；试剂1（R1）：2×50mL，试剂2（R2）：2×10mL；试剂1（R1）：2×50mL，试剂2（R2）：1×20mL；试剂1（R1）：4×50mL，试剂2（R2）：4×10mL；试剂1（R1）：4×50mL，试剂2（R2）：2×20mL；试剂1（R1）：2×60mL，试剂2（R2）：2×12mL；试剂1（R1）：3×60mL，试剂2（R2）：1×36mL；试剂1（R1）：2×48mL，试剂2（R2）: 2×17mL；试剂1（R1）：4×48mL，试剂2（R2）: 4×17mL；试剂1（R1）：2×37mL，试剂2（R2）: 2×11mL；试剂1（R1）：4×37mL，试剂2（R2）: 4×11mL； 2×440测试（适用于Atellica，ADVIA XPT）； 4×440测试（适用于Atellica，ADVIA XPT)； 4×300测试（适用于罗氏cobas 8000 c701、cobas 8000 c702）； 2×200测试（适用于罗氏cobas 8000 c701、cobas 8000 c702）； 2×300测试（适用于日立LABOSPECT 008 AS）； 4×400测试（适用于日立LABOSPECT 008 AS）； 1×250测试（适用于F-C800p）； 2×250测试（适用于F-C800p）； 4×250测试（适用于F-C800p）；校准品（选配）：1×1mL；质控品（选配）：1×1mL。

Approval Department

Shanghai Municipal Drug Administration

上海市药品监督管理局

Registration Information

Registration Number

沪械注准20232400081

Approval Date

April 07, 2023

Expiry Date

April 06, 2028

Registrant

Name

Shanghai Fosun LONG March MEDICAL Science Co., Ltd.

复星诊断科技（上海）有限公司

Province/Region

Shanghai

上海

Address

830 Chengyin Road, Baoshan District, Shanghai

上海市宝山区城银路830号

Production Facility

Production Address

上海市宝山区城银路830号

Structure and Composition

English

Reagent 1: phosphate buffer, oxidized glutathione; Reagent 2: Good's buffer, NADPH; Calibrator: Glutathione Reductase, Good's Buffer; Control: Glutathione Reductase, Good's Buffer

中文

试剂1: 磷酸盐缓冲液、氧化型谷胱甘肽；试剂2：Good's缓冲液、NADPH；校准品：谷胱甘肽还原酶、 Good's缓冲液；质控品：谷胱甘肽还原酶、 Good's缓冲液

Storage Conditions and Expiration

English

1. Under the storage conditions of 2~8 °C protected from light and sealed, the validity period is 12 months from the date of production. 2. After reagent 1 and reagent 2 are enabled, they can be stable for 30 days under the condition of 2~10 °C protected from light. 3. After the calibrator and quality control products are opened, they are stored under the condition of 18~25 °C and protected from light, which can be stable for 6 hours.

中文

1.在2～8℃避光、密封的储存条件下，自生产之日起有效期为12个月。 2.试剂1和试剂2启用后，在2～10℃避光的条件下可稳定30天。 3.校准品、质控品开瓶后，在18～25℃避光的条件下贮存，可稳定6小时。