Serosep L T D

FDA Filings

This page includes the latest FDA filings for Serosep 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: 3006255827
• FEI Number: 3006255827
• Name: Karl E. Luke, PhD
• Owner & Operator: Serosep Ltd
• Contact Address: Annacotty Business Park Annacotty; Limerick IE-LK Limerick V94 FF83 IE
• US Agent:
  • Karl E. Luke, PhD
  • Diagnostic Hybrids, Inc. - a subsidiary of Quidel Corporatio
  • 740 5893382
  • 740 5929729
  • karl.luke@quidel.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2005 East State Street, Suite 100 ; Athens, OH 45701 US
• Establishment Type:
  • Manufacture Medical Device
  • Foreign Private Label Distributor

FDA Filings

Device Company	Device	Date
JQW Karl E. Luke, PhD [Serosep Ltd]	EntericBio? Workstation	2019-07-10
PMN K182703 | PCH Karl E. Luke, PhD [Serosep Ltd]	EntericBio? Dx Assay	2019-07-09
PMN K182703 Serosep, Ltd.	EntericBio Dx Assay	2019-06-19