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鲁械注准20242401108

Fibrinogen (FIB) detection test kit (coagulation method)

纤维蛋白原（FIB）检测试剂盒（凝固法）
Shandong Kanghua Biotechnology Co., Ltd.·Class II·NMPA·Approved December 19, 2024
Device classification
Device class
Class II
Model specifications
FIB 凝血酶试剂:5×2mLFIB 缓冲液:2×12mL; FIB 凝血酶试剂:5×2mLFIB 缓冲液:4×6mL; FIB 凝血酶试剂:5×2mLFIB 缓冲液:2×51mL; FIB 凝血酶试剂:10×1mLFIB 缓冲液:2×12mL; FIB 凝血酶试剂:10×2mLFIB 缓冲液:4×12mL; FIB 凝血酶试剂:10×2mLFIB 缓冲液:8×6mL; FIB 凝血酶试剂:10×2mLFIB 缓冲液:2×25mL; FIB 凝血酶试剂:10×4mLFIB 缓冲液:7×12mL; FIB 凝血酶试剂:10×4mLFIB 缓冲液:2×51mL; FIB 凝血酶试剂:10×5mLFIB 缓冲液:2×51mL; FIB 校准品(选配):1×1.0 mL
FIB 凝血酶试剂：5×2mLFIB 缓冲液：2×12mL； FIB 凝血酶试剂：5×2mLFIB 缓冲液：4×6mL； FIB 凝血酶试剂：5×2mLFIB 缓冲液：2×51mL； FIB 凝血酶试剂：10×1mLFIB 缓冲液：2×12mL； FIB 凝血酶试剂：10×2mLFIB 缓冲液：4×12mL； FIB 凝血酶试剂：10×2mLFIB 缓冲液：8×6mL； FIB 凝血酶试剂：10×2mLFIB 缓冲液：2×25mL； FIB 凝血酶试剂：10×4mLFIB 缓冲液：7×12mL； FIB 凝血酶试剂：10×4mLFIB 缓冲液：2×51mL； FIB 凝血酶试剂：10×5mLFIB 缓冲液：2×51mL； FIB 校准品（选配）：1×1.0 mL
Approval department
Shandong Provincial Drug Administration
山东省药品监督管理局
Registration information
Registration number
鲁械注准20242401108
Approval date
December 19, 2024
Expiry date
December 18, 2029
Registrant
Name
Shandong Kanghua Biotechnology Co., Ltd.
山东康华生物医疗科技股份有限公司
Province/Region
Shandong
山东
Address
No. 699, Yuehe Road, Weifang Economic Development Zone
潍坊经济开发区月河路699号
Production facility
Production address
潍坊经济开发区古亭街8877号
Intended use
English

用于体外定量检测人血浆中纤维蛋白原(FIB)含量.

中文

用于体外定量检测人血浆中纤维蛋白原（FIB）含量。

Structure and composition
English

FIB凝血酶试剂:4-羟乙基哌嗪乙磺酸(13g/L)、凝血酶(125mg/L)、Proclin 300(防腐剂)(1mL/L); FIB缓冲液:咪唑(3.404g/L). FIB校准品(选配)(冻干):纤维蛋白原(靶值批特异,见盒内靶值单)、Proclin 300(防腐剂)(1mL/L).

中文

FIB凝血酶试剂：4-羟乙基哌嗪乙磺酸（13g/L）、凝血酶（125mg/L）、Proclin 300（防腐剂）（1mL/L）； FIB缓冲液：咪唑（3.404g/L）。 FIB校准品（选配）（冻干）：纤维蛋白原（靶值批特异，见盒内靶值单）、Proclin 300（防腐剂）（1mL/L）。

Storage conditions and expiration
English

试剂盒2～8℃密封保存,有效期为12个月.

中文

试剂盒2～8℃密封保存，有效期为12个月。

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

Access comprehensive regulatory information for Fibrinogen (FIB) detection test kit (coagulation 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 鲁械注准20242401108 and owned by Shandong Kanghua Biotechnology Co., Ltd.. The device was approved on December 19, 2024.

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