Alkaline Phosphatase Assay Reagent Kit (NPP Substrate-AMP Buffer Method) - NMPA Registration 沪械注准20172400302

Access comprehensive regulatory information for Alkaline Phosphatase Assay Reagent Kit (NPP Substrate-AMP Buffer 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20172400302 and owned by Shanghai Fosun LONG March MEDICAL Science Co., Ltd.. The device was approved on October 29, 2021.

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20172400302

Alkaline Phosphatase Assay Reagent Kit (NPP Substrate-AMP Buffer Method)

碱性磷酸酶测定试剂盒（NPP底物-AMP缓冲液法）

NMPA Registration Number: 沪械注准20172400302

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Intended Use

English

It is used by medical institutions to quantitatively detect the activity of alkaline phosphatase in human serum or plasma in vitro for auxiliary diagnosis.

中文

供医疗机构用于体外定量检测人血清或血浆中碱性磷酸酶的活性，作辅助诊断用。

Device Classification

Device Class

Class II

Model Specifications

Reagent 1 (R1): 4×50mL, Reagent 2(R2): 1×50mL; Reagent 1 (R1): 4×50mL, Reagent 2(R2): 2×25mL; Reagent 1(R1): 4×40mL, Reagent 2(R2): 4×10mL; Reagent 1(R1): 2×40mL, Reagent 2(R2): 2×10mL; Reagent 1(R1): 2×32mL, Reagent 2(R2): 2×8mL; Reagent 1(R1): 2×24mL, Reagent 2(R2): 2×6mL; Reagent 1(R1): 2×48mL, Reagent 2(R2): 2×18mL; Reagent 1(R1): 4×48mL, Reagent 2(R2): 4×18mL; Reagent 1 (R1): 4×60 mL; Reagent 2 (R2): 1×60 mL; Reagent 1 (R1): 2×250 test, Reagent 2 (R2): 1×500 test; 2×440 test (applicable to Siemens Atellica, ADVIA XPT models); 4×440 test (applicable to Siemens Atellica, ADVIA XPT models); 2×200 test (applicable to Roche COBAS 8000 C701, COBAS 8000 C702, COBAS 8000 C502, COBAS 6000 C501); 4×300 test (applicable to Roche COBAS 8000 C701, COBAS 8000 C702, COBAS 8000 C502, COBAS 6000 C501); 2×300 test (for Hitachi LABOSPECT 008 AS, LABOSPECT 006 models); 4×400 test (applicable to Hitachi LABOSPECT 008 AS, LABOSPECT 006 models); 2×250 test (applicable to Changxing CX-2110, F-C800, F-C800p, F-1100x models); 4×250 test (for Changxing CX-2110, F-C800, F-C800p, F-1100x models).

试剂1（R1）：4×50mL、试剂2（R2）：1×50mL；试剂1（R1）：4×50mL、试剂2（R2）：2×25mL；试剂 1（R1）：4×40mL、试剂 2（R2）：4×10mL；试剂 1（R1）：2×40mL、试剂 2（R2）：2×10mL；试剂 1（R1）：2×32mL、试剂 2（R2）：2×8mL；试剂 1（R1）：2×24mL、试剂 2（R2）：2×6mL；试剂1（R1）：2×48mL、试剂2（R2）：2×18mL ；试剂1（R1）：4×48mL、试剂2（R2）：4×18mL；试剂1（R1）：4×60mL；试剂2（R2）：1×60mL；试剂1（R1）：2×250测试、试剂2（R2）：1×500测试； 2×440测试（适用西门子Atellica、ADVIA XPT机型）； 4×440测试（适用西门子Atellica、ADVIA XPT机型）；2×200测试（适用罗氏cobas 8000 c701、cobas 8000 c702、cobas 8000 c502、cobas 6000 c501机型）； 4×300测试（适用罗氏cobas 8000 c701、cobas 8000 c702、cobas 8000 c502、cobas 6000 c501机型）； 2×300测试（适用日立LABOSPECT 008 AS、LABOSPECT 006 机型）； 4×400测试（适用日立LABOSPECT 008 AS、LABOSPECT 006机型）； 2×250测试（适用长星CX-2110、F-C800、F-C800p、F-1100x机型）； 4×250测试（适用长星CX-2110、F-C800、F-C800p、F-1100x机型）。

Approval Department

Shanghai Municipal Drug Administration

上海市药品监督管理局

Registration Information

Registration Number

沪械注准20172400302

Approval Date

October 29, 2021

Expiry Date

April 25, 2027

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

R1: magnesium acetate, zinc sulfate, HEDTA, AMP buffer; R2: p-nitrobenzene phosphate, HEDTA, AMP buffer. Product validity period: 12 months. Accessories: product standards, product manuals.

中文

R1：乙酸镁、硫酸锌、HEDTA、AMP缓冲液；R2：对-硝基苯磷酸盐、HEDTA、AMP缓冲液。产品有效期：12个月。附件：产品标准，产品说明书。

Additional Information

Remark

原注册证号：沪械注准20172400302

Changes

注册人名称由“上海复星长征医学科学有限公司”变更为“复星诊断科技（上海）有限公司”。,1. 医疗器械注册证变更包括新增包装规格，延长产品有效期至18个月，详见附件1 (共1页）。2. 产品技术要求新增包装规格及文字性变更，详见附件2(共5页）。3. 产品说明书的变更包括变更适用机型、新增包装规格、延长效期至18个月、明确最大可稀释倍数及其他文字性变更，详见附件3(共7页）。

Appendix

产品技术要求、产品说明书