Free thyroxine (FT4) detection reagent kit (magnetic particle chemiluminescence method)
- Device class
- Class II
- Model specifications
- 50 servings/box, 50 servings/box (with calibrators), 100 servings/box, 100 servings/box (with calibration), 200 servings/box, 200 servings/box (with calibration), 300 servings/box, 300 people/box (with calibration), 2×100 people/box, 2×100 people/box (with calibrator), 3×100 people/box, 3×100 people/box (with calibration)50人份/盒、50人份/盒（含校准品）、100人份/盒、100人份/盒（含校准品）、200人份/盒、200人份/盒（含校准品）、300人份/盒、300人份/盒（含校准品）、2×100人份/盒、2×100人份/盒（含校准品）、3×100人份/盒、3×100人份/盒（含校准品）
- Approval department
- Fujian Provincial Drug Administration福建省药品监督管理局
- Registration number
- 闽械注准20242400174
- Approval date
- September 20, 2024
- Expiry date
- September 19, 2029
- Name
- Xiamen Innodx BIOTECH Co., Ltd.厦门万泰凯瑞生物技术有限公司
- Province/Region
- Fujian福建
- Address
- 2nd floor, No. 124, Xinyuan Road, Xinyang Street, Haicang District, Xiamen厦门市海沧区新阳街道新园路124号2楼
- Production address
- 厦门市海沧区新阳街道新园路120号6层4单元、126号（1楼、4楼A区）、130号4号楼（A区、B区）和5号楼
This reagent is used for the quantitative detection of free thyroxine (FT4) in human serum and plasma. Clinically, it is mainly used to assist in the evaluation of thyroid function.
本试剂用于定量检测人血清和血浆中的游离甲状腺素(FT4)。临床上主要用于辅助评价甲状腺功能。.
Reagent 1: Biotinylated T4 antibody (sheep derived) and avidin-coated magnetic particles. Reagent 2: Acridine ester-labeled T4 antigen. Reagent 3: Buffer containing surfactant. Calibrator 1: FT4 containing 6.40pmol/L~11.58pmol/L prepared with hormone-free stromal blood. Calibrator 2: FT4 containing 38.61pmol/L~77.22pmol/L prepared with hormones-free matrix blood.
试剂1：生物素标记的T4抗体（羊源）和亲和素包被的磁微粒。 试剂2：吖啶酯标记的T4抗原。 试剂3：含表面活性剂的缓冲液。 校准品1：含有去激素基质血配制的6.40pmol/L～11.58pmol/L的FT4。 校准品2：含有去激素基质血配制的38.61pmol/L～77.22pmol/L的FT4。.
Store at 2~8°C, valid for 12 months.
2～8℃保存，有效期12个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Free thyroxine (FT4) detection reagent kit (magnetic particle 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 闽械注准20242400174 and owned by Xiamen Innodx BIOTECH Co., Ltd.. The device was approved on September 20, 2024.
This page provides complete registration details including registrant information, province location (Fujian), 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.