Helena Laboratories Uk L T D

FDA Filings

This page includes the latest FDA filings for Helena Laboratories Uk 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: 3009736003
• FEI Number: 3009736003
• Name: Helena Laboratories UK Ltd
• Owner & Operator: Helena Biosciences Europe
• Contact Address: Queensway South Team Valley Trading Estate; Gateshead GB-GAT Gateshead NE11 0SD GB
• Official Correspondent:
  • Carol J Sandercock
  • 44-191-5160554-220
• US Agent:
  • Justin Padia
  • Regulatory Affairs
  • 409 8423714 1275
  • JPadia@helena.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Queensway South Team Valley Trading Estate; Gateshead Newcastle upon Tyne, NE11 0SD GB
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
CEF Helena Laboratories UK Ltd [Helena Biosciences Europe]	V8 Urine Preparation Buffer SPE	2012-07-27
CEF Helena Laboratories UK Ltd [Helena Biosciences Europe]	V8 Urine Preparation Buffer SP6	2012-07-27
CEF Helena Laboratories UK Ltd [Helena Biosciences Europe]	V8 Urine Preparation Buffer SP6 Zoom	2012-07-27
CEF Helena Laboratories UK Ltd [Helena Biosciences Europe]	V8 Storage Buffer	2012-07-27
CEF Helena Laboratories UK Ltd [Helena Biosciences Europe]	V8 Serum Protein SPE Kit	2012-07-27
CEF Helena Laboratories UK Ltd [Helena Biosciences Europe]	V8 Serum Protein SPE Buffer (single)	2012-07-27
CEF Helena Laboratories UK Ltd [Helena Biosciences Europe]	V8 Serum Protein 6 Band Zoom Kit	2012-07-27
CEF Helena Laboratories UK Ltd [Helena Biosciences Europe]	V8 Serum Protein 6 Band Zoom Buffer (single)	2012-07-27
CEF Helena Laboratories UK Ltd [Helena Biosciences Europe]	V8 Serum Protein 6 Band Kit	2012-07-27
CEF Helena Laboratories UK Ltd [Helena Biosciences Europe]	V8 Serum Protein 6 Band Buffer (single)	2012-07-27
CEF Helena Laboratories UK Ltd [Helena Biosciences Europe]	V8 Maintenance Buffer	2012-07-27
PMN K111369 | CFF Helena Laboratories UK Ltd [Helena Biosciences Europe]	V8 Immunodisplacement Kit	2012-07-17
PMN K111369 HELENA LABORATORIES UK LTD	THE HELENA V8 IMMUNODISPLACEMENT KIT	2012-06-26