Linkgen Biotech Shanghai Co L T D

FDA Filings

This page includes the latest FDA filings for Linkgen Biotech Shanghai Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3015169734
• FEI Number: 3015169734
• Name: Fiona Chan
• Owner & Operator: LinkGen Biotech (Shanghai) Co.,ltd.
• Contact Address: Room 3313,3th Floor, Room B, No. 17, Lan Jinzhong Road, Changning District; Shanghai CN-31 Shanghai 200335 CN
• US Agent:
  • Fiona Chan
  • SUNGO Technical Service Inc.
  • 855 9577779
  • sungo.group@yahoo.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 6050 W EASTWOOD AVE APT 201 ; Chicago, IL 60630 US
• Establishment Type:
  • Manufacture Medical Device
  • Export Device to the United States But Perform No Other Operation on Device

FDA Filings

Device Company	Device	Date
KXG Fiona Chan [LinkGen Biotech (Shanghai) Co.,ltd.]	Disposable Sterile Sampling Brush	2019-12-09
KXG Fiona Chan [LinkGen Biotech (Shanghai) Co.,ltd.]	Disposable Sterile Cervical Sampler	2019-12-09
KXG Fiona Chan [LinkGen Biotech (Shanghai) Co.,ltd.]	Disposable Sampling Swab	2019-12-09
KXG Fiona Chan [LinkGen Biotech (Shanghai) Co.,ltd.]	Disposable Cell Preservation Solution Sterile Sampling Brush	2019-12-09
GIO Fiona Chan [LinkGen Biotech (Shanghai) Co.,ltd.]	Disposable cfDNA blood collection	2019-12-09
FAQ Fiona Chan [LinkGen Biotech (Shanghai) Co.,ltd.]	Integrated quantitative urine collection	2019-12-09
JAY Fiona Chan [LinkGen Biotech (Shanghai) Co.,ltd.]	artificial cannulation support strap	2019-02-15
KXF Fiona Chan [LinkGen Biotech (Shanghai) Co.,ltd.]	Genolocker specimen collection swab	2019-02-01
JJH Fiona Chan [LinkGen Biotech (Shanghai) Co.,ltd.]	MicroLocker Spin Column fecal Genomic DNA Extraction Kit(50T/100T/200T)	2019-02-01
JJH Fiona Chan [LinkGen Biotech (Shanghai) Co.,ltd.]	MicroLocker Separate fecal sampling kit	2019-02-01
JJH Fiona Chan [LinkGen Biotech (Shanghai) Co.,ltd.]	MicroLocker Magnetic beads fecal Genomic DNA Extraction Kit(50T/100T/200T)	2019-02-01
JJH Fiona Chan [LinkGen Biotech (Shanghai) Co.,ltd.]	MicroLocker Integrated fecal sampling kit	2019-02-01
JJH Fiona Chan [LinkGen Biotech (Shanghai) Co.,ltd.]	Genolocker oral swab DNA sampling kit	2019-02-01
JJH Fiona Chan [LinkGen Biotech (Shanghai) Co.,ltd.]	Genolocker Magnetic beads Saliva Genomic DNA extraction Kit(50T/100T/200T)	2019-02-01
FMH Fiona Chan [LinkGen Biotech (Shanghai) Co.,ltd.]	Genolocker Separate saliva DNA collector kit	2019-02-01
FMH Fiona Chan [LinkGen Biotech (Shanghai) Co.,ltd.]	Genolocker Integrated saliva DNA collector kit	2019-02-01
FMH Fiona Chan [LinkGen Biotech (Shanghai) Co.,ltd.]	Disposable virus sampling swab kit ; Disposable Virus Sampling Tube	2019-02-01