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 Number: 3014553740
• FEI Number: 3014553740
• Name: Lindsey Howard
• Owner & Operator: QIAGEN, GmbH
• Contact Address: QIAGEN STRASSE 1 --; HILDEN DE-NOTA 40724 DE
• US Agent:
  • Lindsey Howard
  • QIAGEN
  • 240 6867826
  • lindsey.howard@qiagen.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 19300 Germantown Road ; Germantown, MD 20874 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 3004013603
• FEI Number: 3004013603
• Name: Lindsey Howard
• Owner & Operator: QIAGEN, GmbH
• Contact Address: QIAGEN STRASSE 1 --; HILDEN DE-NOTA 40724 DE
• 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: 19300 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	Device	Date
GUDID 04053228047438 QIAGEN GmbH	QIAstat-Dx® Respiratory Panel Plus 691224	2024-06-25
GUDID 04053228043249 QIAGEN GmbH	QIAstat-Dx® Gastrointestinal Panel 2 691421	2024-06-25
GUDID 04053228045861 QIAGEN GmbH	QIAamp® DSP DNA FFPE Tissue Kit 60404	2022-12-15
GUDID 04053228045854 QIAGEN GmbH	QIAamp® DSP Virus Kit 60704	2022-12-15
GUDID 04053228045847 QIAGEN GmbH	QIAamp® DSP DNA Blood Mini Kit 61104	2022-12-15
GUDID 04053228045830 QIAGEN GmbH	QIAamp DSP Circulating NA Kit (50) 61504	2022-12-15
GUDID 04053228045823 QIAGEN GmbH	QIAamp® DSP Virus Spin Kit 61704	2022-12-15
GUDID 04053228045816 QIAGEN GmbH	EZ1® DSP DNA Blood Kit 62124	2022-12-15
GUDID 04053228045809 QIAGEN GmbH	EZ1® DSP Virus Kit 62724	2022-12-15
GUDID 04053228045793 QIAGEN GmbH	QIAsymphony® DSP Virus/Pathogen Mini Kit 937036	2022-12-15
GUDID 04053228045786 QIAGEN GmbH	QIAsymphony® DSP Virus/Pathogen Midi Kit 937055	2022-12-15
GUDID 04053228045779 QIAGEN GmbH	QIAsymphony® DSP DNA Mini Kit 937236	2022-12-15
GUDID 04053228045762 QIAGEN GmbH	QIAsymphony® DSP DNA Midi Kit 937255	2022-12-15
GUDID 04053228031024 QIAGEN GmbH	RNeasy® DSP FFPE Kit 73604	2022-12-15
GUDID 04053228030072 QIAGEN GmbH	QIAsymphony® DSP Circulating DNA Kit 937556	2022-12-15
GUDID 04053228039129 QIAGEN GmbH	QIAcube Connect MDx 9003070	2022-09-08
GUDID 04053228043560 QIAGEN GmbH	therascreen® FGFR RGQ RT-PCR Kit 874721	2022-05-31
PMA P180043S003 QIAGEN GmbH	therascreen FGFR RGQ RT-PCR Kit	2021-11-16
PMA P120022S022 QIAGEN GmbH	therascreen EGFR RGQ PCR Kit	2021-07-07
GUDID 04053228040996 QIAGEN GmbH	CMV Probe ASR 1124264	2021-06-10
GUDID 04053228040972 QIAGEN GmbH	CMV Primer ASR 1124260	2021-06-10
PMA P110027S012 QIAGEN GmbH	therascreen KRAS RGQ PCR KIT	2021-05-28
GUDID 04053228002062 QIAGEN GmbH	therascreen® EGFR RGQ PCR Kit 870121	2020-05-06
GUDID 04053228002048 QIAGEN GmbH	therascreen® KRAS RGQ PCR Kit 870021	2020-05-06
PMA P190026 QIAGEN GmbH	therascreen BRAF V600E RGQ PCR Kit	2020-04-15
PMA P190001S001 QIAGEN GMBH	therascreen PIK3CA RGQ PCR Kit	2020-04-03
PMA P180043S002 QIAGEN GmbH	therascreen FGFR RGQ PCR Kit	2020-04-03
PMA P120022S021 QIAGEN GmbH	therascreen EGFR RGQ PCR Kit	2020-04-03
PMA P110027S011 QIAGEN GmbH	therascreen KRAS RGQ PCR Kit	2020-04-03
QJR Lindsey Howard [QIAGEN, GmbH]	QIAstat-Dx Respiratory SARS-CoV-2 Panel	2020-04-01
QJR Lindsey Howard [QIAGEN, GmbH]	QIAstat-Dx Respiratory SARS-CoV-2 Panel	2020-04-01
GUDID 04053228033905 QIAGEN GmbH	QIAstat-Dx® Respiratory Panel 691221	2019-10-28
GUDID 04053228034223 QIAGEN GmbH	therascreen® PIK3CA RGQ PCR Kit 873121	2019-06-13
GUDID 04053228033936 QIAGEN GmbH	QIAstat-Dx® Analyzer 1.0 9002824	2019-06-03
PMN P190001 | OWD Lindsey Howard [QIAGEN, GmbH]	therascreen? PIK3CA RGQ PCR Kit	2019-05-29
PMA P190004 QIAGEN GmbH	therascreen PIK3CA PLASMA RGQ PCR Kit	2019-05-24
PMA P190001 QIAGEN GMBH	therascreen PIK3CA RGQ PCR Kit	2019-05-24
PMN K183597 | OZZ Lindsey Howard [QIAGEN, GmbH]	QIAstat-Dx? Respiratory Panel	2019-05-22
PMN K183597 | OZZ Lindsey Howard [QIAGEN, GmbH]	QIAstat-Dx? Respiratory Panel	2019-05-22
PMN K183597 | OZY Lindsey Howard [QIAGEN, GmbH]	QIAstat-Dx? Respiratory Panel	2019-05-22
PMN K183597 | OZY Lindsey Howard [QIAGEN, GmbH]	QIAstat-Dx? Respiratory Panel	2019-05-22
PMN K183597 | OZX Lindsey Howard [QIAGEN, GmbH]	QIAstat-Dx? Respiratory Panel	2019-05-22
PMN K183597 | OZX Lindsey Howard [QIAGEN, GmbH]	QIAstat-Dx? Respiratory Panel	2019-05-22
PMN K183597 | OTG Lindsey Howard [QIAGEN, GmbH]	QIAstat-Dx? Respiratory Panel	2019-05-22
PMN K183597 | OTG Lindsey Howard [QIAGEN, GmbH]	QIAstat-Dx? Respiratory Panel	2019-05-22
PMN K183597 | OQW Lindsey Howard [QIAGEN, GmbH]	QIAstat-Dx? Respiratory Panel	2019-05-22
PMN K183597 | OQW Lindsey Howard [QIAGEN, GmbH]	QIAstat-Dx? Respiratory Panel	2019-05-22
PMN K183597 | OOU Lindsey Howard [QIAGEN, GmbH]	QIAstat-Dx? Respiratory Panel	2019-05-22
PMN K183597 | OOU Lindsey Howard [QIAGEN, GmbH]	QIAstat-Dx? Respiratory Panel	2019-05-22
PMN K183597 | OOI Lindsey Howard [QIAGEN, GmbH]	QIAstat-Dx? Respiratory Panel	2019-05-22
PMN K183597 | OOI Lindsey Howard [QIAGEN, GmbH]	QIAstat-Dx? Respiratory Panel	2019-05-22
PMN K183597 | OEP Lindsey Howard [QIAGEN, GmbH]	QIAstat-Dx? Respiratory Panel	2019-05-22
PMN K183597 | OEP Lindsey Howard [QIAGEN, GmbH]	QIAstat-Dx? Respiratory Panel	2019-05-22
PMN K183597 | OEM Lindsey Howard [QIAGEN, GmbH]	QIAstat-Dx? Respiratory Panel	2019-05-22
PMN K183597 | OEM Lindsey Howard [QIAGEN, GmbH]	QIAstat-Dx? Respiratory Panel	2019-05-22
PMN K183597 | OCC Lindsey Howard [QIAGEN, GmbH]	QIAstat-Dx? Respiratory Panel	2019-05-22
PMN K183597 | OCC Lindsey Howard [QIAGEN, GmbH]	QIAstat-Dx? Respiratory Panel	2019-05-22
OOI Lindsey Howard [QIAGEN, GmbH]	QIAstat-Dx? Analyzer 1.0	2019-05-22
PMN K183597 QIAGEN GmbH	QIAstat-Dx Respiratory Panel	2019-05-18
GUDID 04053228034094 QIAGEN GmbH	therascreen® FGFR RGQ RT-PCR Kit 874721	2019-05-07
GUDID 04053228034469 QIAGEN GmbH	aLF Reader 9002764	2019-04-23
PMN P180043 | OWD Lindsey Howard [QIAGEN, GmbH]	therascreen? FGFR RGQ RT-PCR Kit	2019-04-18
PMA P180043 QIAGEN GmbH	therascreen FGFR RGQ RT-PCR Kit	2019-04-12
JJQ Lindsey Howard [QIAGEN, GmbH]	aLF Lateral Flow Reader	2019-04-12
GUDID 04053228024538 QIAGEN GmbH	artus® CMV QS-RGQ MDx Kit 4503346	2018-07-06
GUDID 04053228015444 QIAGEN GmbH	ipsogen® JAK2 RGQ PCR Kit 673633	2018-07-06
GUDID 04053228002086 QIAGEN GmbH	artus® CMV RGQ MDx Kit 4503245	2018-07-06
GUDID 04053228010838 QIAGEN GmbH	Rotor-Gene® Q MDx 9002035	2018-03-29
GUDID 04053228010821 QIAGEN GmbH	Rapid Capture System 6000-3101	2018-03-29
GUDID 04053228010760 QIAGEN GmbH	EZ1 Advanced XL 9001492	2018-03-29
GUDID 04053228010753 QIAGEN GmbH	EZ1 Advanced 9001411	2018-03-29
GUDID 04053228010746 QIAGEN GmbH	QIAsymphony AS 9001301	2018-03-29
GUDID 04053228010739 QIAGEN GmbH	QIAsymphony SP 9001297	2018-03-29
GUDID 04053228010722 QIAGEN GmbH	QIAcube 9001292	2018-03-29
GUDID 04053228004660 QIAGEN GmbH	artus® HSV-1/2 QS-RGQ MDx Kit 4526346	2018-03-29
GUDID 04053228004646 QIAGEN GmbH	artus® C. difficile QS-RGQ MDx Kit 4572346	2018-03-29
GUDID 04053228004592 QIAGEN GmbH	QIAsymphony DSP DNA Mini Kit 937236	2018-03-29
GUDID 04053228004585 QIAGEN GmbH	QIAsymphony DSP Virus/Pathogen Midi Kit 937055	2018-03-29
GUDID 04053228004578 QIAGEN GmbH	QIAsymphony DSP Virus/Pathogen Mini Kit 937036	2018-03-29
GUDID 04053228004561 QIAGEN GmbH	EZ1 DSP DNA Blood Kit 62124	2018-03-29
GUDID 04053228004448 QIAGEN GmbH	BK Virus Positive Control 1067395	2018-03-29
GUDID 04053228004431 QIAGEN GmbH	BK Virus Probe ASR 1067392	2018-03-29
GUDID 04053228004424 QIAGEN GmbH	BK Virus Primer ASR 1067391	2018-03-29
GUDID 04053228004417 QIAGEN GmbH	HSV-1 Probe ASR 1066155	2018-03-29
GUDID 04053228004400 QIAGEN GmbH	VZV Positive Control 1067295	2018-03-29
GUDID 04053228004394 QIAGEN GmbH	VZV Probe ASR 1067291	2018-03-29
GUDID 04053228004387 QIAGEN GmbH	HSV Positive Control 1066176	2018-03-29
GUDID 04053228004370 QIAGEN GmbH	HSV-2 Probe ASR 1066160	2018-03-29
GUDID 04053228004363 QIAGEN GmbH	HSV Primer ASR 1066150	2018-03-29
GUDID 04053228004356 QIAGEN GmbH	VZV Primer ASR 1067287	2018-03-29
GUDID 04053228003519 QIAGEN GmbH	QIAensemble Decapper System 9001923	2018-03-29
GUDID 04053228002963 QIAGEN GmbH	QIAamp DSP Circulating DNA Kit 61504	2018-03-29
GUDID 04053228002918 QIAGEN GmbH	QIAamp DSP Viral RNA Mini Kit 61904	2018-03-29
GUDID 04053228002901 QIAGEN GmbH	QIAamp DSP Virus Spin Kit 61704	2018-03-29
GUDID 04053228002895 QIAGEN GmbH	QIAamp DSP DNA Mini Kit 61304	2018-03-29
GUDID 04053228002871 QIAGEN GmbH	QIAamp DSP DNA FFPE Tissue Kit 60404	2018-03-29
GUDID 04053228002758 QIAGEN GmbH	QIAGEN Proteinase K 19134	2018-03-29
GUDID 04053228001898 QIAGEN GmbH	QIAsymphony DSP DNA Midi Kit 937255	2018-03-29
GUDID 04053228001850 QIAGEN GmbH	QIAsymphony DSP AXpH DNA Kit 937156	2018-03-29
GUDID 04053228000099 QIAGEN GmbH	EZ1 DSP Virus Kit 62724	2018-03-29
GUDID 04053228000075 QIAGEN GmbH	QIAamp DSP DNA Blood Mini Kit 61104	2018-03-29
GUDID 04053228000068 QIAGEN GmbH	QIAamp DSP Virus Kit 60704	2018-03-29
PMN DEN160028 | PSU Lindsey Howard [QIAGEN, GmbH]	ipsogen? JAK2 RGQ PCR Kit	2017-05-18
PMN P130027 | PAB Lindsey Howard [QIAGEN, GmbH]	artus CMV RGQ MDx Kit	2014-08-19
PMN P130027 | PAB Lindsey Howard [QIAGEN, GmbH]	artus CMV QS-RGQ MDx Kit	2014-08-19
PMN K133936 QIAGEN, GMBH	ARTUS C. DIFFICILE QS-RGQ MDX KIT	2014-04-04
PMN K113319 | OOI Lindsey Howard [QIAGEN, GmbH]	Rotor-Gene Q MDx	2012-06-08
PMN K113319 | OOI Lindsey Howard [QIAGEN, GmbH]	QIAsymphony RGQ MDx	2012-06-08
PMN K113323 QIAGEN, GMBH	ARTUS INFL A/B RG RT-PCR KIT	2012-02-06
PMN K113319 QIAGEN, GMBH	ROTOR-GENE Q MDX	2012-02-06
OHQ Lindsey Howard [QIAGEN, GmbH]	VZV Positive Control	2011-03-03
OHQ Lindsey Howard [QIAGEN, GmbH]	HSV Positive Control	2011-03-03
OHQ Lindsey Howard [QIAGEN, GmbH]	EBV Positive Controls	2011-03-03
OHQ Lindsey Howard [QIAGEN, GmbH]	BK Virus Positive Control	2011-03-03
JJH Lindsey Howard [QIAGEN, GmbH]	RNeasy DSP FFPE Kit	2008-06-19
JJH Lindsey Howard [QIAGEN, GmbH]	QIAsymphony SP	2008-06-19
JJH Lindsey Howard [QIAGEN, GmbH]	QIAsymphony DSP Virus/Pathogen Kits	2008-06-19
JJH Lindsey Howard [QIAGEN, GmbH]	QIAsymphony DSP DNA Kits	2008-06-19
JJH Lindsey Howard [QIAGEN, GmbH]	QIAsymphony DSP Circulating DNA Kit	2008-06-19
JJH Lindsey Howard [QIAGEN, GmbH]	QIAsmphony DSP AXpH DNA Kit	2008-06-19
JJH Lindsey Howard [QIAGEN, GmbH]	QIAcube	2008-06-19
JJH Lindsey Howard [QIAGEN, GmbH]	QIAamp DSP Virus Spin Kit	2008-06-19
JJH Lindsey Howard [QIAGEN, GmbH]	QIAamp DSP Virus Kit	2008-06-19
JJH Lindsey Howard [QIAGEN, GmbH]	QIAamp DSP Viral RNA Mini Kit	2008-06-19
JJH Lindsey Howard [QIAGEN, GmbH]	QIAamp DSP DNA Mini Kit	2008-06-19
JJH Lindsey Howard [QIAGEN, GmbH]	QIAamp DSP DNA FFPE Tissue Kit	2008-06-19
JJH Lindsey Howard [QIAGEN, GmbH]	QIAamp DSP DNA Blood Mini Kit	2008-06-19
JJH Lindsey Howard [QIAGEN, GmbH]	QIAamp DSP Circulating NA Kit	2008-06-19
JJH Lindsey Howard [QIAGEN, GmbH]	EZ1 DSP Virus Kit	2008-06-19
JJH Lindsey Howard [QIAGEN, GmbH]	EZ1 DSP DNA Blood Kit	2008-06-19
JJH Lindsey Howard [QIAGEN, GmbH]	EZ1 Advanced XL	2008-06-19
JQW Lindsey Howard [QIAGEN, GmbH]	QIAensemble Decapper	2006-03-02
PMN DEN050003 | NTW Lindsey Howard [QIAGEN, GmbH]	PAXGENE (TM) BLOOD RNA SYSTEM	2005-11-04
PPM Lindsey Howard [QIAGEN, GmbH]	QIAGEN Proteinase K	2005-07-05
PPM Lindsey Howard [QIAGEN, GmbH]	HotStarTaq? DNA Polymerase	2005-07-05
PPM Lindsey Howard [QIAGEN, GmbH]	Deparaffinization solution	2005-07-05
PPM Lindsey Howard [QIAGEN, GmbH]	Buffer N2	2005-07-05
PPM Lindsey Howard [QIAGEN, GmbH]	Buffer D2	2005-07-05
PPM Lindsey Howard [QIAGEN, GmbH]	Buffer AVL	2005-07-05
PPM Lindsey Howard [QIAGEN, GmbH]	Buffer ATL	2005-07-05
PPM Lindsey Howard [QIAGEN, GmbH]	Buffer ACL	2005-07-05
MVU Lindsey Howard [QIAGEN, GmbH]	VZV Probe ASR	2005-07-05
MVU Lindsey Howard [QIAGEN, GmbH]	VZV Primer ASR	2005-07-05
MVU Lindsey Howard [QIAGEN, GmbH]	HSV-2 Probe ASR	2005-07-05
MVU Lindsey Howard [QIAGEN, GmbH]	HSV-1 Probe ASR	2005-07-05
MVU Lindsey Howard [QIAGEN, GmbH]	HSV Primer ASR	2005-07-05
MVU Lindsey Howard [QIAGEN, GmbH]	EBV Probe ASR	2005-07-05
MVU Lindsey Howard [QIAGEN, GmbH]	EBV Primer ASR	2005-07-05
MVU Lindsey Howard [QIAGEN, GmbH]	BK Virus Probe ASR	2005-07-05
MVU Lindsey Howard [QIAGEN, GmbH]	BK Virus Primer ASR	2005-07-05

Similar & Related FDA Registered Companies

• QIAGEN Lake Constance GmbH
• QIAGEN19300 Germantown Roadgermantown, MD 20874 PMA NumberP010033 Supplement NumberS048 Date Received09/30/2022 Decision Date01/24/2023 Product Code NCD  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• QIAGEN GmbHqiagen Strasse 1hilden 40724 PMA NumberP110027 Supplement NumberS015 Date Received06/15/2022 Decision Date07/11/2022 Product Code OWD  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• QIAGEN GmbHqiagen Strasse 1hilden 40724 PMA NumberP110027 Supplement NumberS014 Date Received05/19/2022 Decision Date06/17/2022 Product Code OWD  Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	DM143	QIAGEN GMBH
CAGE Code	DM143	QIAGEN GMBH
S.A.M. Registration	DM143 [317103745]	QIAGEN GMBH

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020031325651	Anvers,Belgium -> Baltimore, Maryland	PRODUCTS FOR GENETIC RESEARCH	7 PKG
2020031225979	Anvers,Belgium -> Baltimore, Maryland	PRODUCTS FOR GENETIC RESEARCH	7 PAL
2020031042420	Anvers,Belgium -> Baltimore, Maryland	PRODUCTS FOR GENETIC RESEARCH	7 PAL
2020011717845	Bremerhaven,Federal Republic of Germany -> Baltimore, Maryland	PRODUCTS FOR GENETIC RESEARCH HS CODE: 39269097	11 PKG
2019100540721	Anvers,Belgium -> Baltimore, Maryland	PRODUCTS FOR GENETIC RESEARCH HS CODE: 39269097	12 PKG
2019092415940	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	ZIP LOCK PLASTIC COLLECTION TUBE	5 PKG
2019091254586	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	ZIP LOCK PLASTIC COLLECTION TUBE	5 PKG
2019062133585	Anvers,Belgium -> Baltimore, Maryland	QSCREW CAP & QBOTTLES HS-CODE: 39269097, 49011000 , 48191000 , 39232100,48211010 48219010, 481920 39233010, 39233010 39235010, 481920	11 PKG