China NMPA legacy archive 闽械注准20242400174Free 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)
- Approval department
- Fujian Provincial Drug Administration
- Registration number
- 闽械注准20242400174
- Approval date
- September 20, 2024
- Expiry date
- September 19, 2029
- Province/Region
- Fujian
- Address
- 2nd floor, No. 124, Xinyuan Road, Xinyang Street, Haicang District, Xiamen
- 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
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