鲁械注准20152400645

Free Triiodothyronine Test Kit (Chemiluminescence Method)

游离三碘甲状腺原氨酸检测试剂盒(化学发光法)
Weifang Kanghua Biotechnology Co., Ltd·Class II·NMPA·Approved July 30, 2020
Device classification
Device class
Class II
Model specifications
48 servings/box, 96 servings/box.
48人份/盒、96人份/盒。
Approval department
Shandong Provincial Drug Administration
山东省药品监督管理局
Registration information
Registration number
鲁械注准20152400645
Approval date
July 30, 2020
Expiry date
July 29, 2025
Registrant
Name
Weifang Kanghua Biotechnology Co., Ltd
潍坊市康华生物技术有限公司
Province/Region
Shandong
山东
Address
No. 699, Yuehe Road, Weifang Economic Development Zone
潍坊市经济开发区月河路699号
Production facility
Production address
潍坊市经济开发区月河路699号
Intended use
English

This kit is used for the in vitro quantitative determination of free triiodothyronine in human serum.

中文

该试剂盒用于体外定量测定人血清中的游离三碘甲状腺原氨酸的含量。

Structure and composition
English

Coated slats, reference S0 (0pmol/L), reference S1 (3.75 pmol/L), reference S2 (7.5 pmol/L), reference S3 (15pmol/L), reference S4 (30pmol/L), reference S5 (60pmol/L), control Q1, control Q2, enzyme conjugate, concentrated washing solution (40×), substrate solution A, substrate liquid B, sealing film. The main components of the kit components are: coated slats: triiodothyronine antibodies; Reference S0: Reference diluent; Reference S1-S5: Triiodothyronine antigen, reference dilution; Quality control Q1, Q2: triiodothyronine antigen, reference dilution; Enzyme conjugates: triiodothyronine antigen; Concentrated washing solution (40×): sodium chloride, sodium dihydrogen phosphate, disodium hydrogen phosphate; Substrate A: bovine serum albumin, tromethamine, luminol; Substrate B: bovine serum albumin, trobuthamine, hydrogen peroxide.

中文

包被板条、参考品S0(0pmol/L)、参考品S1(3.75 pmol/L)、参考品S2(7.5pmol/L)、参考品S3(15pmol/L)、参考品S4(30pmol/L)、参考品S5(60pmol/L)、质控品Q1、质控品Q2、酶结合物、浓缩洗涤液(40×)、底物液A、底物液B、封板膜。 试剂盒组成部分的主要组成的成分为:包被板条:三碘甲状腺原氨酸抗体;参考品S0:参考品稀释液;参考品S1-S5:三碘甲状腺原氨酸抗原、参考品稀释液;质控品Q1、Q2:三碘甲状腺原氨酸抗原、参考品稀释液;酶结合物:三碘甲状腺原氨酸抗原;浓缩洗涤液(40×):氯化钠、磷酸二氢钠、磷酸氢二钠;底物液A:牛血清白蛋白、氨基丁三醇、鲁米诺;底物液B:牛血清白蛋白、氨基丁三醇、过氧化氢。

Storage conditions and expiration
English

The kit is stored in a dark and dry place at 2~8 °C, not frozen, and the validity period is 12 months.

中文

试剂盒于2~8℃避光、干燥处贮存,不得冻存,有效期为12个月。

About this record

Access comprehensive regulatory information for Free Triiodothyronine Test Kit (Chemiluminescence 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20152400645 and owned by Weifang Kanghua Biotechnology Co., Ltd. The device was approved on July 30, 2020.

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.