CE Onayı Reddetme ISO 13485 ile NS1 Antigen Hızlı Test

• Type: Rapid Diagnostic Test
• biçim: kaset
• örnek: tam kan/serum/plazma
• kutu özellikleri: 40 test/kutu
• ağırlık/karton: 20,00 kg
• sertifika: ce sertifikası ve iso 13485
• Hayır. Modeli.: 101011
• raf ömrü: 24 ay
• test süresi: 15 dakika
• kullanım: profesyonel kullanım veya evde kullanım
• cihaz sınıflandırması: sınıf iii
• kalite sertifikası: ce
• Taşıma Paketi: 66*36*56.5cm
• Teknik Özelikler: 268*124*65mm
• Ticari Marka: Testsealabs
• Menşei: China
• HS Kodu: 3822190090
• Üretim Kapasitesi: 3000000/Day

Ürün Açıklaması

 

Product Description

Format	Cassette
Specimen	Whole Blood/Serum/Plasma
Box Specification	40 Tests/Box
Certificate	CE Certificate & ISO 13485
Shelf Life	24 Months
Usage	Professional Use or Home Use
Instrument Classification	Class III
Box Size	268*124*65mm
Carton Size	66*36*56.5cm

Detailed Photos

Test Procedure

 

Company Profile

Hangzhou Testsea Biotechnology Co., LTD. is a national high-tech enterprise, is located in Hangzhou. Testsea has lots of researchers and workers who graduated from Zhejiang University and overseas. Testsea is specialized in the research, development, production and sales of raw materials for medical diagnosis and food safety testing. We have applied for 28 kinds of patents which cover medical diagnosis, food safety rapid testing, food enzymatic immunoassay and new enzyme preparation. Testsea provides perfect raw material solutions for scientific research institutions, enterprises, research institutes and other institutions globally. Testsea total business area is more than 56,000 square meters, including 2,000 square meters of GMP 100,000-level purification workshop, our company is strictly following ISO13485 and ISO9001 quality management system operation with research, production, quality control, finance, domestic sales and international sales, etc. Our products are well accepted by many users domestic and abroad. In addition, we establish a good business relationship with many domestic universities and in vitro diagnostic production enterprises, even with southeast Asia, Europe, Africa, Latin America, and other countries.

Testsea has a research and development team led by doctors and masters with professional workers and a well-equipment facility. The production capacity of recombinant antigens has reached 18g/month.

Testsea pursuit of "integrity, quality, responsibility" concept and adhere to the quality, the purpose of serving the society and constantly developing new high-quality diagnostic materials efforts.

Certifications