Jei Daniel Biotech Corp

FDA Filings

This page includes the latest FDA filings for Jei Daniel Biotech Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3008962922
• FEI Number: 3008962922
• Name: JEI DANIEL BIOTECH CORP.
• Owner & Operator: Jei Daniel Biotech Corp.
• Contact Address: A201, Building 1, No.69, Hua Yang Road ; Jinan CN-37 Shandong 250100 CN
• US Agent:
  • William Slevin
  • Medapproval LLC
  • 864 7352466
  • qara@medapprovalllc.com
• Importing Logistics Registration:
  • Importer: Inverness Medical, Llc
  • Address: 51 Sawyer Rd. Suite 200 ; South Waltham, MA 02453 UNITED STATES
• Importing Logistics Registration:
  • Importer: Southern Sales
  • Address: 4400 Commerical Cirlce ; ATL, GA 30336 UNITED STATES
  • Phone: 1 404 4192938
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: A201, Building 1, No.69, Hua Yang Road ; Jinan Shandong, 250100 CN
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
NGE JEI DANIEL BIOTECH CORP.	Luteinizing Hormone (LH) Rapid Test Kit, Jei Daniel Ovulation Test, LH Kit	2015-06-10
NGA JEI DANIEL BIOTECH CORP.	FSH Test, Follicle Stimulating Hormone (FSH) Rapid Test Kit, Jei Daniel Menopause Test	2015-06-10
JJQ JEI DANIEL BIOTECH CORP.	Immuno Gold Q-Reader, Desktop Reader, Immuno Gold Reader for Lateral Flow Assay Analysis	2014-08-21
MJM JEI DANIEL BIOTECH CORP.	JD Gardnerella Vaginalis (B.V) Ag Test Kit, JD Gardnerella Vaginalis Antigen Rapid Test Kit	2013-01-29
LHK JEI DANIEL BIOTECH CORP.	JD Candida Albicans (C. albs) Ag Test Kit, JD Candida Albicans (Yeast) Antigen Rapid Test Kit	2013-01-29
JWZ JEI DANIEL BIOTECH CORP.	JD Gardnerella Vaginalis (B.V) Ag Test Kit, JD Gardnerella Vaginalis Antigen Rapid Test Kit	2013-01-29