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China NMPA legacy archive 国械注准20243401590

Abnormal prothrombin assay kit (chemiluminescence)

异常凝血酶原测定试剂盒(化学发光法)
Shanghai Kehua Bio-Engineering Co., Ltd.Class IIINMPAApproved August 23, 2024
Static archiveNMPA · legacy registration snapshot
Device classification
Device class
Class III
Model specifications
50 servings/box, 100 servings/box, 2×50 servings/box, 2×100 servings/box.
50人份/盒、100人份/盒、2×50人份/盒、2×100人份/盒。
Approval department
State Drug Administration
国家药品监督管理局
Registration information
Registration number
国械注准20243401590
Approval date
August 23, 2024
Expiry date
August 22, 2029
Registrant
Name
Shanghai Kehua Bio-Engineering Co., Ltd.
上海科华生物工程股份有限公司
Province/Region
Shanghai
上海
Address
1189 Qinzhou North Road, Xuhui District, Shanghai
上海市徐汇区钦州北路1189号
Production facility
Production address
上海市徐汇区桂平路701号
Intended use
English

This product is used for the quantitative determination of abnormal prothrombin content in human serum in vitro.

中文

本产品用于体外定量测定人血清中异常凝血酶原的含量。

Structure and composition
English

Reagent 1 (R1), Reagent 2 (R2), Reagent 3 (R3), Calibration A, Calibrated B, Control 1, Control 2. (Please refer to the manual for details)

中文

试剂1(R1)、试剂2(R2)、试剂3(R3)、定标品A、定标品B、质控品1、质控品2。(具体内容详见说明书)

Storage conditions and expiration
English

Store at 2~8 °C, no freezing, valid for 12 months.

中文

2~8℃储存,禁止冷冻,有效期12个月。

Additional information
Appendix
产品技术要求、说明书
About this record

This static archive preserves historical registration fields and translations for Abnormal prothrombin assay kit (chemiluminescence), registration 国械注准20243401590. 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.