Xiaobing Yu

FDA Filings

This page includes the latest FDA filings for Xiaobing Yu. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 0
• FEI Number: 0
• Name: XIAOBING YU
• Owner & Operator: Suzhou Herui BioMed Co. ,Ltd
• Contact Address: Room 310/312/313, Floor B2, Bi ological ; SUZHOU CN-32 Jiangsu 215000 CN
• Official Correspondent:
  • TING YAO
  • 86-0512-80963713-x
• US Agent:
  • XIAOBING YU
  • 240 4980502
  • china@sophisters.com
• Registration Status: 5
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 781 Coronada Ln Foster City; Foster City, CA 94404 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GIF XIAOBING YU [Suzhou Herui BioMed Co. ,Ltd]	Herui BioMed Sample Diluent special for COVID-19 Testing kit	2020-04-09
PMN K192123 | LCX XIAOBING YU [Suzhou Herui BioMed Co. ,Ltd]	Herui BioMed Novel Coronavirus (2019-nCoV ) IgG/IgM Antibody Detection Kit	2020-04-04
GNH XIAOBING YU [Suzhou Herui BioMed Co. ,Ltd]	Novel Coronavirus (2019-nCoV ) IgG/IgM Antibody Detection Kit	2020-04-04