Qiagen G M B H

FDA Filings

This page includes the latest FDA filings for Qiagen G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3014553740
FEI Number3014553740
NameLindsey Howard
Owner & OperatorQIAGEN, GmbH
Contact AddressQIAGEN STRASSE 1 --
HILDEN DE-NOTA 40724 DE
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address19300 Germantown Road
Germantown, MD 20874 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number3004013603
FEI Number3004013603
NameLindsey Howard
Owner & OperatorQIAGEN, GmbH
Contact AddressQIAGEN STRASSE 1 --
HILDEN DE-NOTA 40724 DE
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address19300 Germantown Rd
Germantown, MD 20874 US
Establishment Type
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility



FDA Owner/Operator Registration

FDA Filings

Device
Company
DeviceDate
QIAGEN GmbH
therascreen® EGFR RGQ PCR Kit 8701212020-05-06
QIAGEN GmbH
therascreen® KRAS RGQ PCR Kit 8700212020-05-06
QIAGEN GmbH
therascreen BRAF V600E RGQ PCR Kit2020-04-15
QIAGEN GMBH
therascreen PIK3CA RGQ PCR Kit2020-04-03
QIAGEN GmbH
therascreen FGFR RGQ PCR Kit2020-04-03
QIAGEN GmbH
therascreen EGFR RGQ PCR Kit2020-04-03
QIAGEN GmbH
therascreen KRAS RGQ PCR Kit2020-04-03
Lindsey Howard [QIAGEN, GmbH]
QIAstat-Dx Respiratory SARS-CoV-2 Panel2020-04-01
Lindsey Howard [QIAGEN, GmbH]
QIAstat-Dx Respiratory SARS-CoV-2 Panel2020-04-01
QIAGEN GmbH
QIAstat-Dx® Respiratory Panel 6912212019-10-28
QIAGEN GmbH
therascreen® PIK3CA RGQ PCR Kit 8731212019-06-13
QIAGEN GmbH
QIAstat-Dx® Analyzer 1.0 9002824 2019-06-03
Lindsey Howard [QIAGEN, GmbH]
therascreen? PIK3CA RGQ PCR Kit2019-05-29
QIAGEN GmbH
therascreen PIK3CA PLASMA RGQ PCR Kit2019-05-24
QIAGEN GMBH
therascreen PIK3CA RGQ PCR Kit2019-05-24
Lindsey Howard [QIAGEN, GmbH]
QIAstat-Dx? Respiratory Panel2019-05-22
Lindsey Howard [QIAGEN, GmbH]
QIAstat-Dx? Respiratory Panel2019-05-22
Lindsey Howard [QIAGEN, GmbH]
QIAstat-Dx? Respiratory Panel2019-05-22
Lindsey Howard [QIAGEN, GmbH]
QIAstat-Dx? Respiratory Panel2019-05-22
Lindsey Howard [QIAGEN, GmbH]
QIAstat-Dx? Respiratory Panel2019-05-22
Lindsey Howard [QIAGEN, GmbH]
QIAstat-Dx? Respiratory Panel2019-05-22
Lindsey Howard [QIAGEN, GmbH]
QIAstat-Dx? Respiratory Panel2019-05-22
Lindsey Howard [QIAGEN, GmbH]
QIAstat-Dx? Respiratory Panel2019-05-22
Lindsey Howard [QIAGEN, GmbH]
QIAstat-Dx? Respiratory Panel2019-05-22
Lindsey Howard [QIAGEN, GmbH]
QIAstat-Dx? Respiratory Panel2019-05-22
Lindsey Howard [QIAGEN, GmbH]
QIAstat-Dx? Respiratory Panel2019-05-22
Lindsey Howard [QIAGEN, GmbH]
QIAstat-Dx? Respiratory Panel2019-05-22
Lindsey Howard [QIAGEN, GmbH]
QIAstat-Dx? Respiratory Panel2019-05-22
Lindsey Howard [QIAGEN, GmbH]
QIAstat-Dx? Respiratory Panel2019-05-22
Lindsey Howard [QIAGEN, GmbH]
QIAstat-Dx? Respiratory Panel2019-05-22
Lindsey Howard [QIAGEN, GmbH]
QIAstat-Dx? Respiratory Panel2019-05-22
Lindsey Howard [QIAGEN, GmbH]
QIAstat-Dx? Respiratory Panel2019-05-22
Lindsey Howard [QIAGEN, GmbH]
QIAstat-Dx? Respiratory Panel2019-05-22
Lindsey Howard [QIAGEN, GmbH]
QIAstat-Dx? Respiratory Panel2019-05-22
Lindsey Howard [QIAGEN, GmbH]
QIAstat-Dx? Respiratory Panel2019-05-22
Lindsey Howard [QIAGEN, GmbH]
QIAstat-Dx? Analyzer 1.02019-05-22
QIAGEN GmbH
QIAstat-Dx Respiratory Panel2019-05-18
QIAGEN GmbH
therascreen® FGFR RGQ RT-PCR Kit 8747212019-05-07
QIAGEN GmbH
aLF Reader 90027642019-04-23
Lindsey Howard [QIAGEN, GmbH]
therascreen? FGFR RGQ RT-PCR Kit2019-04-18
QIAGEN GmbH
therascreen FGFR RGQ RT-PCR Kit2019-04-12
Lindsey Howard [QIAGEN, GmbH]
aLF Lateral Flow Reader2019-04-12
QIAGEN GmbH
artus® CMV QS-RGQ MDx Kit 45033462018-07-06
QIAGEN GmbH
ipsogen® JAK2 RGQ PCR Kit 6736332018-07-06
QIAGEN GmbH
artus® CMV RGQ MDx Kit 45032452018-07-06
QIAGEN GmbH
Rotor-Gene® Q MDx 90020352018-03-29
QIAGEN GmbH
Rapid Capture System 6000-31012018-03-29
QIAGEN GmbH
EZ1 Advanced XL 90014922018-03-29
QIAGEN GmbH
EZ1 Advanced 90014112018-03-29
QIAGEN GmbH
QIAsymphony AS 90013012018-03-29
QIAGEN GmbH
QIAsymphony SP 90012972018-03-29
QIAGEN GmbH
QIAcube 90012922018-03-29
QIAGEN GmbH
artus® HSV-1/2 QS-RGQ MDx Kit 45263462018-03-29
QIAGEN GmbH
artus® C. difficile QS-RGQ MDx Kit 45723462018-03-29
QIAGEN GmbH
QIAsymphony DSP DNA Mini Kit 9372362018-03-29
QIAGEN GmbH
QIAsymphony DSP Virus/Pathogen Midi Kit 9370552018-03-29
QIAGEN GmbH
QIAsymphony DSP Virus/Pathogen Mini Kit 9370362018-03-29
QIAGEN GmbH
EZ1 DSP DNA Blood Kit 621242018-03-29
QIAGEN GmbH
BK Virus Positive Control 10673952018-03-29
QIAGEN GmbH
BK Virus Probe ASR 10673922018-03-29
QIAGEN GmbH
BK Virus Primer ASR 10673912018-03-29
QIAGEN GmbH
HSV-1 Probe ASR 10661552018-03-29
QIAGEN GmbH
VZV Positive Control 10672952018-03-29
QIAGEN GmbH
VZV Probe ASR 10672912018-03-29
QIAGEN GmbH
HSV Positive Control 10661762018-03-29
QIAGEN GmbH
HSV-2 Probe ASR 10661602018-03-29
QIAGEN GmbH
HSV Primer ASR 10661502018-03-29
QIAGEN GmbH
VZV Primer ASR 10672872018-03-29
QIAGEN GmbH
QIAensemble Decapper System 90019232018-03-29
QIAGEN GmbH
QIAamp DSP Circulating DNA Kit 615042018-03-29
QIAGEN GmbH
QIAamp DSP Viral RNA Mini Kit 619042018-03-29
QIAGEN GmbH
QIAamp DSP Virus Spin Kit 617042018-03-29
QIAGEN GmbH
QIAamp DSP DNA Mini Kit 613042018-03-29
QIAGEN GmbH
QIAamp DSP DNA FFPE Tissue Kit 604042018-03-29
QIAGEN GmbH
QIAGEN Proteinase K 191342018-03-29
QIAGEN GmbH
QIAsymphony DSP DNA Midi Kit 9372552018-03-29
QIAGEN GmbH
QIAsymphony DSP AXpH DNA Kit 9371562018-03-29
QIAGEN GmbH
EZ1 DSP Virus Kit 627242018-03-29
QIAGEN GmbH
QIAamp DSP DNA Blood Mini Kit 611042018-03-29
QIAGEN GmbH
QIAamp DSP Virus Kit 607042018-03-29
Lindsey Howard [QIAGEN, GmbH]
ipsogen? JAK2 RGQ PCR Kit2017-05-18
Lindsey Howard [QIAGEN, GmbH]
artus CMV RGQ MDx Kit2014-08-19
Lindsey Howard [QIAGEN, GmbH]
artus CMV QS-RGQ MDx Kit2014-08-19
QIAGEN, GMBH
ARTUS C. DIFFICILE QS-RGQ MDX KIT2014-04-04
Lindsey Howard [QIAGEN, GmbH]
Rotor-Gene Q MDx2012-06-08
Lindsey Howard [QIAGEN, GmbH]
QIAsymphony RGQ MDx2012-06-08
QIAGEN, GMBH
ARTUS INFL A/B RG RT-PCR KIT2012-02-06
QIAGEN, GMBH
ROTOR-GENE Q MDX2012-02-06
Lindsey Howard [QIAGEN, GmbH]
VZV Positive Control2011-03-03
Lindsey Howard [QIAGEN, GmbH]
HSV Positive Control2011-03-03
Lindsey Howard [QIAGEN, GmbH]
EBV Positive Controls2011-03-03
Lindsey Howard [QIAGEN, GmbH]
BK Virus Positive Control2011-03-03
Lindsey Howard [QIAGEN, GmbH]
RNeasy DSP FFPE Kit2008-06-19
Lindsey Howard [QIAGEN, GmbH]
QIAsymphony SP2008-06-19
Lindsey Howard [QIAGEN, GmbH]
QIAsymphony DSP Virus/Pathogen Kits2008-06-19
Lindsey Howard [QIAGEN, GmbH]
QIAsymphony DSP DNA Kits2008-06-19
Lindsey Howard [QIAGEN, GmbH]
QIAsymphony DSP Circulating DNA Kit2008-06-19
Lindsey Howard [QIAGEN, GmbH]
QIAsmphony DSP AXpH DNA Kit2008-06-19
Lindsey Howard [QIAGEN, GmbH]
QIAcube2008-06-19
Lindsey Howard [QIAGEN, GmbH]
QIAamp DSP Virus Spin Kit2008-06-19
Lindsey Howard [QIAGEN, GmbH]
QIAamp DSP Virus Kit2008-06-19
Lindsey Howard [QIAGEN, GmbH]
QIAamp DSP Viral RNA Mini Kit2008-06-19
Lindsey Howard [QIAGEN, GmbH]
QIAamp DSP DNA Mini Kit2008-06-19
Lindsey Howard [QIAGEN, GmbH]
QIAamp DSP DNA FFPE Tissue Kit2008-06-19
Lindsey Howard [QIAGEN, GmbH]
QIAamp DSP DNA Blood Mini Kit2008-06-19
Lindsey Howard [QIAGEN, GmbH]
QIAamp DSP Circulating NA Kit2008-06-19
Lindsey Howard [QIAGEN, GmbH]
EZ1 DSP Virus Kit2008-06-19
Lindsey Howard [QIAGEN, GmbH]
EZ1 DSP DNA Blood Kit2008-06-19
Lindsey Howard [QIAGEN, GmbH]
EZ1 Advanced XL2008-06-19
Lindsey Howard [QIAGEN, GmbH]
QIAensemble Decapper2006-03-02
Lindsey Howard [QIAGEN, GmbH]
PAXGENE (TM) BLOOD RNA SYSTEM2005-11-04
Lindsey Howard [QIAGEN, GmbH]
QIAGEN Proteinase K2005-07-05
Lindsey Howard [QIAGEN, GmbH]
HotStarTaq? DNA Polymerase2005-07-05
Lindsey Howard [QIAGEN, GmbH]
Deparaffinization solution2005-07-05
Lindsey Howard [QIAGEN, GmbH]
Buffer N22005-07-05
Lindsey Howard [QIAGEN, GmbH]
Buffer D22005-07-05
Lindsey Howard [QIAGEN, GmbH]
Buffer AVL2005-07-05
Lindsey Howard [QIAGEN, GmbH]
Buffer ATL2005-07-05
Lindsey Howard [QIAGEN, GmbH]
Buffer ACL2005-07-05
Lindsey Howard [QIAGEN, GmbH]
VZV Probe ASR2005-07-05
Lindsey Howard [QIAGEN, GmbH]
VZV Primer ASR2005-07-05
Lindsey Howard [QIAGEN, GmbH]
HSV-2 Probe ASR2005-07-05
Lindsey Howard [QIAGEN, GmbH]
HSV-1 Probe ASR2005-07-05
Lindsey Howard [QIAGEN, GmbH]
HSV Primer ASR2005-07-05
Lindsey Howard [QIAGEN, GmbH]
EBV Probe ASR2005-07-05
Lindsey Howard [QIAGEN, GmbH]
EBV Primer ASR2005-07-05
Lindsey Howard [QIAGEN, GmbH]
BK Virus Probe ASR2005-07-05
Lindsey Howard [QIAGEN, GmbH]
BK Virus Primer ASR2005-07-05

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