Shenzhen Kinetic Biotech Co., Ltd.
快速检测试剂盒 OEM 专门从事生殖健康、药物筛选和食品安全侧向层析检测。
Kinetic Biotech 是一家合同开发和制造组织 (CDMO)，提供横向流动免疫分析快速测试，涵盖排卵预测、妊娠、药物滥用、食物过敏原检测和兽医诊断。该公司为欧洲、澳大利亚和北美的自有品牌客户进行研发、测试线涂层、卡片组装和最终包装。
- Type
- Manufacturer
- Location
- Shenzhen, China
- Founded
- 2009
- Website
- kineticbiotech.com
- Categories
- 医疗保健用品
- Markets
- 中国, 美国, 德国, 澳大利亚, 新加坡
Claimed certifications
- ISO 9001, Quality Management IAF CertSearch
- ISO 13485, Medical Devices Quality IAF CertSearch
- CE Marking EU NANDO (notified bodies)
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)