Qiagen Manchester L T D

FDA Filings

This page includes the latest FDA filings for Qiagen Manchester 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: 3005118020
• FEI Number: 3009391812
• Name: QIAGEN Manchester Ltd
• Owner & Operator: QIAGEN Manchester Ltd
• Contact Address: Skelton House Lloyd Street North; Manchester GB-LAN Lancashire M15 6SH GB
• Official Correspondent:
  • Chris Bray
  • 044-161-2041220-x
• US Agent:
  • Lindsey Howard
  • QIAGEN Sciences LLC
  • 240 6867826
  • 240 6867827
  • lindsey.howard@qiagen.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Skelton House Lloyd Street North; Manchester Lancashire, M15 6SH GB
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
PMA P120022S020 QIAGEN MANCHESTER LTD	therascreen EGFR RGQ PCR Kit	2019-09-26
PMA P120022S018 QIAGEN MANCHESTER LTD	therascreen EGFR RGQ PCR Kit	2018-09-27
PMA P120022S019 QIAGEN MANCHESTER LTD	therascreen EGFR RGQ PCR Kit	2018-04-06
PMA P110027S010 QIAGEN MANCHESTER LTD	therascreen KRAS RGQ PCR Kit	2018-04-06
PMA P120022S017 QIAGEN MANCHESTER LTD	therascreen EGFR RGQ PCR kit	2018-02-22
PMA P120022S016 QIAGEN MANCHESTER LTD	Therascreen EGFR RGQ PCR Kit	2018-01-12
PMN K113319 | OOI QIAGEN Manchester Ltd	Rotor-Gene Q MDx	2017-12-15
PMN K113319 | OOI QIAGEN Manchester Ltd	QIAsymphony RGQ MDx	2017-12-15
PMN K113319 | OOI QIAGEN Manchester Ltd	QIAstat-Dx? Analyzer 1.0	2017-12-15
JJH QIAGEN Manchester Ltd	QIAsymphony SP	2017-12-14
JJH QIAGEN Manchester Ltd	QIAcube	2017-12-14
JJH QIAGEN Manchester Ltd	EZ1 Advanced XL	2017-12-14
PMA P120022S015 QIAGEN MANCHESTER LTD	Therascreen EGFR, RGQ, PCR Kit	2017-07-24
PMA P120022S014 QIAGEN MANCHESTER LTD	THERASCREEN EGFR RGQ PCR KIT	2017-05-19
PMA P120022S013 QIAGEN MANCHESTER LTD	THERASCREEN EGFR RGQ PCR KIT	2016-09-07
PMA P120022S012 QIAGEN MANCHESTER LTD	THERASCREEN EGFR RGQ PCR KIT	2015-11-09
PMA P110027S009 QIAGEN MANCHESTER LTD	THERASCREEN KRAS RGQ PCR KIT	2015-11-09
PMA P120022S010 QIAGEN MANCHESTER LTD	THERASCREEN EGFR RGQ PCR KIT	2015-08-06
PMA P110027S008 QIAGEN MANCHESTER LTD	THERASCREEN KRAS RGQ PCR KIT	2015-08-06
PMA P120022S001 QIAGEN MANCHESTER LTD	THERASCEEN EGFR RGQ PCR KIT	2015-07-10
PMA P120022S009 QIAGEN MANCHESTER LTD	QIAGEN THERASCREEN EGFR RGQ PCR KIT	2015-04-24
PMA P110027S007 QIAGEN MANCHESTER LTD	QIAGEN THERASCREEN KRAS RGQ PCR KIT	2015-04-24
PMA P120022S008 QIAGEN MANCHESTER LTD	QIAGEN THERASCREEN EGFR RGQ PCR KIT	2015-04-23
PMA P110027S006 QIAGEN MANCHESTER LTD	QIAGEN THERASCREEN KRAS RGQ PCR KIT	2015-04-23
PMA P120022S007 QIAGEN MANCHESTER LTD	THERASCREEN EGFR RGQ PCR KIT	2015-02-19
PMA P110027S005 QIAGEN MANCHESTER LTD	THERASCREEN KRAS RGQ PCR KIT	2015-02-19
PMA P120022S006 QIAGEN MANCHESTER LTD	QIAGEN THERASCREEN EGFR RGQ PCR KIT	2015-02-13
PMA P110027S004 QIAGEN MANCHESTER LTD	QIAGEN THERASCREEN KRAS RGQ PCR KIT	2015-02-13
PMA P120022S005 QIAGEN MANCHESTER LTD	THERASCREEN EGFR RGQ PCR KIT	2015-01-16
PMA P110027S003 QIAGEN MANCHESTER LTD	THERASCREEN KRAS RGQ PCR KIT	2015-01-16
PMA P120022S004 QIAGEN MANCHESTER LTD	THERASCREEN EGFR RGQ PCR KIT	2015-01-15
PMA P110027S002 QIAGEN MANCHESTER LTD	THERASCREEN KRAS RGQ PCR KIT	2015-01-15
PMA P120022S002 QIAGEN MANCHESTER LTD	THERASCREEN EGFR RGQ PCR KIT	2014-12-19
PMA P110027 QIAGEN MANCHESTER LTD	THERASCREEN KRAS RGQ PCR KIT	2014-05-23
PMA P120022 QIAGEN MANCHESTER LTD	THERASCREEN EGFR RGQ PCR KIT	2013-07-12
PMA P110030 QIAGEN MANCHESTER LTD	THERASCREEN KRAS RGQ PCR KIT	2012-07-06