Fetal Fibronectin Test Ffn Rapid Test
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- Model NO.: FT-F11
- Material: Plastic
- Ethylene Oxide Sterilization: Ethylene Oxide Sterilization
- Group: Adult
- Medical Device Regulatory Type: Type 2
- Specimen: Vaginal Discharge
- Trademark: OEM
- Specification: OEM
- HS Code: 3822001000
- Type: Test Strips & Test Tube
- Certification: CE
- Quality Guarantee Period: Two Years
- Logo Printing: With Logo Printing
- Format: Strip/Device
- Storage: 2--30.C
- Transport Package: OEM
- Origin: China
fFN (Fetal Fibronectin) Test Kit
Fetal fibronectin(fFN) is secreted by amnion, decidua, and chorion. It exists in glycosidoprotein between the decidua and chorion, playing a role in the adhesion to the caul. After the pregnant for 21 weeks, the release of fFn is prevented by the integration of chorion and decidua. Therefore, when the normal pregnant women are at their 22 to 35 weeks of gestation, the content of fFn is very low. When the chorion separates with decidua, the extracellular matrix on the interface of both chorion and decidua are damaged by mechanical damage, and the proteolytic enzymes degradate, the fFN leaks into the secretion of the posterior fornix. The level of fFN in cervicovaginal secretions during 22 to 35 weeks of pregnancy have a good correlation with the premature labor.
Diagnostic kit for fetal fibronectin( Colloidal gold) adopts the principle of double antibody sandwich method and colloidal gold immune chromatography.
Packaging Details: Strip: 1pc/foil pouch, 50 or 100pcs/box, 5000pcs/ctn
Cassette: 1pc/foil pouch, 25pcs/box, 1000pcs/ctn
Delivery Detail: Shipped in 30 days after payment
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Hangzhou Singclean Medical Products Co.Ltd
Hangzhou Singclean Medical Products Co., Ltd., established in March 2003 with registered capital of 80,000,000 RMB, is a national high and new technology enterprise integrating the R&D, production and sales of medical biomaterials. With well-qualified staff, thorough quality management system and first-class facilities, the company ensures the continuous production of medical devices and drug injection products of Class III that confirm to the laws and regulations of the State Food and Drug Administration (SFDA) and EU MDD.
The company set up a joint research center with Zhejiang University of Science and Technology, and has well established R & D cooperation relations with Zhejiang University, Donghua University and Zhejiang University of Technology, developing four series of new products with proprietary intellectual property rights, and with a variety of high-tech products to be developed cooperatively. The company also built an R & D platform for medical biomaterials that keeps up with the international level, and made major breakthrough in many key technologies such as those for stopping bleeding, anti-adhesion, and tissue engineering basic materials, with more than 10 patents obtained and a number of products applying for the patents.
The company passed the ISO9001 quality management system certification and ISO13485 medical devices quality management system certification in 2007, and obtained in 2008 the Innovation Fund Certificate certified by the Ministry of Science and Technology with her MPH hemostatic microspheres project. The company obtained the certification of high and new technology enterprise of Hangzhou in 2007, of Zhejiang Province in 2008, of China in 2010, and her medical sodium hyaluronatethe gels passed the CE certification in 2011.