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
 QIAcuityDx® Nanoplate 26k 24-well 2600012024-10-08
QIAGEN GmbH
 QIAcuityDx® Universal MasterMix Kit 2601022024-10-08
QIAGEN GmbH
 QIAcuityDx® Universal MasterMix Kit 260101 2024-10-08
QIAGEN GmbH
 QIAcuityDx® Four 9110602024-10-08
QIAGEN GmbH
 QIAsymphony® DSP Circulating DNA Kit (96) 9375552024-10-08
QIAGEN GmbH
 QIAsymphony® DSP Circulating DNA Maxi Kit (192) 9375662024-10-08
QIAGEN GmbH
 QIAGEN Buffer ASL® 190822024-10-08
QIAGEN GmbH
 QIAstat-Dx Analyzer 2.0 90028282024-09-26
QIAGEN GmbH
 QIAstat-Dx® Respiratory Panel Plus 6912242024-06-25
QIAGEN GmbH
 QIAstat-Dx® Gastrointestinal Panel 2 6914212024-06-25
QIAGEN GmbH
 QIAamp® DSP DNA FFPE Tissue Kit 604042022-12-15
QIAGEN GmbH
 QIAamp® DSP Virus Kit 607042022-12-15
QIAGEN GmbH
 QIAamp® DSP DNA Blood Mini Kit 611042022-12-15
QIAGEN GmbH
 QIAamp DSP Circulating NA Kit (50) 615042022-12-15
QIAGEN GmbH
 QIAamp® DSP Virus Spin Kit 617042022-12-15
QIAGEN GmbH
 EZ1® DSP DNA Blood Kit 621242022-12-15
QIAGEN GmbH
 EZ1® DSP Virus Kit 627242022-12-15
QIAGEN GmbH
 QIAsymphony® DSP Virus/Pathogen Mini Kit 9370362022-12-15
QIAGEN GmbH
 QIAsymphony® DSP Virus/Pathogen Midi Kit 9370552022-12-15
QIAGEN GmbH
 QIAsymphony® DSP DNA Mini Kit 9372362022-12-15
QIAGEN GmbH
 QIAsymphony® DSP DNA Midi Kit 9372552022-12-15
QIAGEN GmbH
 RNeasy® DSP FFPE Kit 736042022-12-15
QIAGEN GmbH
 QIAsymphony® DSP Circulating DNA Kit 9375562022-12-15
QIAGEN GmbH
 QIAcube Connect MDx 9003070 2022-09-08
QIAGEN GmbH
 therascreen® FGFR RGQ RT-PCR Kit 8747212022-05-31
QIAGEN GmbH
 therascreen FGFR RGQ RT-PCR Kit2021-11-16
QIAGEN GmbH
 therascreen EGFR RGQ PCR Kit2021-07-07
QIAGEN GmbH
 CMV Probe ASR 11242642021-06-10
QIAGEN GmbH
 CMV Primer ASR 11242602021-06-10
QIAGEN GmbH
 therascreen KRAS RGQ PCR KIT2021-05-28
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

Similar & Related FDA Registered Companies

Related Finance Registrations
NCAGE CodeDM143QIAGEN GMBH
CAGE CodeDM143QIAGEN GMBH
S.A.M. RegistrationDM143 [317103745]QIAGEN GMBH
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020031325651Anvers,Belgium -> Baltimore, MarylandPRODUCTS FOR GENETIC RESEARCH7 PKG
2020031225979Anvers,Belgium -> Baltimore, MarylandPRODUCTS FOR GENETIC RESEARCH7 PAL
2020031042420Anvers,Belgium -> Baltimore, MarylandPRODUCTS FOR GENETIC RESEARCH7 PAL
2020011717845Bremerhaven,Federal Republic of Germany -> Baltimore, MarylandPRODUCTS FOR GENETIC RESEARCH HS CODE: 3926909711 PKG
2019100540721Anvers,Belgium -> Baltimore, MarylandPRODUCTS FOR GENETIC RESEARCH HS CODE: 3926909712 PKG
2019092415940Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyZIP LOCK PLASTIC COLLECTION TUBE5 PKG
2019091254586Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyZIP LOCK PLASTIC COLLECTION TUBE5 PKG
2019062133585Anvers,Belgium -> Baltimore, MarylandQSCREW CAP & QBOTTLES HS-CODE: 39269097, 49011000 , 48191000 , 39232100,48211010 48219010, 481920 39233010, 39233010 39235010, 48192011 PKG
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