Qiagen

FDA Filings

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

Qiagen holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• SCANDINAVIAN GENE SYNTHESIS AB
• Lindsey Howard

FDA Registration(s)

• Registration Number: 1122376
• FEI Number: 3003572099
• Name: QIAGEN
• Owner & Operator: QIAGEN Sciences LLC
• Contact Address: 19300 Germantown Road --; Germantown MD 20874 US
• Official Correspondent:
  • Lindsey - Howard
  • x-240-6867826-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 19300 Germantown Rd ; Germantown, MD 20874 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Manufacture Device in the United States for Export Only

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMA P010033S047 QIAGEN	QuantiFERON®-TB Gold, QuantiFERON®-TB Gold Plus	2021-12-13
PMA P010033S046 QIAGEN	QuantiFERON – TB Gold and QuantiFERON-TB Gold Plus	2019-12-06
PMA P010033S045 QIAGEN	Quantiferon - TB Gold Plus Test	2019-04-29
PMA P010033S044 QIAGEN	QuantiFERON- TB Gold Test and QuantiFERON- TB Gold Plus Test	2019-04-29
PMA P010033S043 QIAGEN	TB Gold and QuantiFERON - TB Gold Plus	2019-03-15
PMA P010033S042 QIAGEN	QuantiFERON - TB Gold Test, QuantiFERON - TB Gold Plus Test	2019-01-04
PMA P010033S041 QIAGEN	QuantiFERON-TB Gold Test / QuantiFERON TB Gold Plus Test	2018-10-30
PMA P010033S040 QIAGEN	QuantiFERON TB Gold Test, QuantiFERON TB Gold Test (reference lab pack), QuantiFERON TB Gold Plus Test, QuantiFERON TB G	2018-10-04
PMA P010033S037 QIAGEN	QuantiFeron TB Gold and QuantiFeron TB Gold Plus	2018-08-24
PMN P160052 | QBB QIAGEN [QIAGEN Sciences LLC]	PartoSure Test	2018-05-23
PMA P010033S039 QIAGEN	QuantiFERON-TB Gold and QuantiFERON-TB Gold Plus	2018-03-27
PMA P010033S038 QIAGEN	QuantiFeron TB Gold and QuantiFeron TB Gold Plus	2018-02-23
PMA P010033S036 QIAGEN	QuantiFERON-TB Gold and QuantiFERON -TB Gold Plus.	2017-12-07
PMA P010033S035 QIAGEN	QuantiFERON - TB Gold Test and TB Gold Plus Test	2017-11-21
PMA P010033S034 QIAGEN	Quantiferon TB Gold	2017-06-20
PMA P010033S031 QIAGEN	QUANTTFERON-TB GOLD Plus	2017-06-07
PMA P010033S033 QIAGEN	QUANTTFERON-TB Gold	2017-05-09
PMA P010033S032 QIAGEN	QuantiFERON-TB GOLD Test	2017-03-07
PMN K030849 | NQM QIAGEN [QIAGEN Sciences LLC]	AmniSure ROM Test Positive and Negative Controls Pack	2016-11-30
PMN K030849 | JJX QIAGEN [QIAGEN Sciences LLC]	AmniSure ROM Test Positive and Negative Controls Pack	2016-11-30
PMA P010033S030 QIAGEN	QUANTIFERON-TB GOLD AND TB GOLD- Test (reference lab pack)	2016-08-25
PMA P010033S029 QIAGEN	QUANTIFERON-TB GOLD AND TB GOLD Test (reference lab pack)	2016-08-19
PMA P010033S028 QIAGEN	QUANTTFERON-TB GOLD AND TB GOLD-IN-THE-TUBE	2016-04-27
PMN K081767 | NQM QIAGEN [QIAGEN Sciences LLC]	AmniSure? ROM (Rupture of [fetal] Membranes) Test	2015-08-18
PMN P010033 | NCD QIAGEN [QIAGEN Sciences LLC]	QuantiFeron?-TB Gold Test	2015-05-28
PMN P010033 | NCD QIAGEN [QIAGEN Sciences LLC]	QuantiFeron?-TB Gold Plus Test	2015-05-28
PMN K142738 QIAGEN	Artus HSV-1/2 QS-RGQ MDx Kit	2014-12-19
PMA P010033S026 QIAGEN	QUANTIFERON-TB GOLD TEST	2014-12-10
PMA P010033S025 QIAGEN	QUANTIFERON- TB GOLD TEST	2014-12-04
PMA P010033S024 QIAGEN	QUANTIFERON TB GOLD IN-TUBE	2014-05-22
PMA P010033S023 QIAGEN	QUANTIFERON -TB GOLD	2014-01-31
MAQ QIAGEN [QIAGEN Sciences LLC]	digene? HPV Genotyping PS Test	2013-09-12
PMA P010033S020 QIAGEN	QUANTIFERON -TB GOLD	2012-11-15
PMA P010033S019 QIAGEN	QUANTIFERON -TB GOLD	2011-10-20
PMA P010033S018 QIAGEN	QUANTIFERON-TB GOLD	2011-08-23
PMA P010033S017 QIAGEN	QUANTIFERON-TB GOLD IN-TUBE	2011-05-26
PMA P010033S016 QIAGEN	QUANTIFERON-TB GOLD IN-TUBE	2010-12-17
PPM QIAGEN [QIAGEN Sciences LLC]	Wash Buffer X 15	2009-10-09
PPM QIAGEN [QIAGEN Sciences LLC]	Probe Diluent	2009-10-09
PPM QIAGEN [QIAGEN Sciences LLC]	Indicator Dye	2009-10-09
PPM QIAGEN [QIAGEN Sciences LLC]	Detection Reagent 2	2009-10-09
PPM QIAGEN [QIAGEN Sciences LLC]	Detection Reagent 1	2009-10-09
PPM QIAGEN [QIAGEN Sciences LLC]	DNR	2009-10-09
PPM QIAGEN [QIAGEN Sciences LLC]	5.5% NP-40	2009-10-09
OHQ QIAGEN [QIAGEN Sciences LLC]	HPV Positive Control 2	2009-10-09
OHQ QIAGEN [QIAGEN Sciences LLC]	HPV Positive Control 1	2009-10-09
OHQ QIAGEN [QIAGEN Sciences LLC]	HPV Negative Control 2	2009-10-09
OHQ QIAGEN [QIAGEN Sciences LLC]	HPV Negative Control 1	2009-10-09
PMN P890064 | MAQ QIAGEN [QIAGEN Sciences LLC]	digene? HC2 High-Risk HPV DNA Test	2008-05-02
PMN P890064 | MAQ QIAGEN [QIAGEN Sciences LLC]	digene? HC2 High-Risk HPV DNA Test (4 plate)	2008-05-02
PMN P890064 | MAQ QIAGEN [QIAGEN Sciences LLC]	digene? HC2 HPV DNA Test	2008-05-02
PMN P890064 | MAQ QIAGEN [QIAGEN Sciences LLC]	DML 3000	2008-05-02
PMN K990023 | LSK QIAGEN [QIAGEN Sciences LLC]	digene? HC2 CT/GC DNA Test, Version 2	2008-05-02
PMN K990023 | LSK QIAGEN [QIAGEN Sciences LLC]	digene? HC2 CT-ID DNA Test, Version 2	2008-05-02
PMN K990023 | LSK QIAGEN [QIAGEN Sciences LLC]	digene? HC2 CT-GC Dual-ID DNA Test, Version 2	2008-05-02
PMN K981485 | LSL QIAGEN [QIAGEN Sciences LLC]	digene? HC2 GC-ID DNA Test, Version 2	2008-05-02
PMN K981485 | LSL QIAGEN [QIAGEN Sciences LLC]	digene? HC2 CT/GC DNA Test, Version 2	2008-05-02
PMN K981485 | LSL QIAGEN [QIAGEN Sciences LLC]	digene? HC2 CT-GC Dual-ID DNA Test, Version 2	2008-05-02
PMN K971586 | HHT QIAGEN [QIAGEN Sciences LLC]	digene? HC2 DNA Collection Device	2008-05-02
MVU QIAGEN [QIAGEN Sciences LLC]	Lyophilized R848	2006-10-31
MVU QIAGEN [QIAGEN Sciences LLC]	Lyophilized Anti-CD3	2006-10-31
MVU QIAGEN [QIAGEN Sciences LLC]	HPV 45 Probe ASR	2006-10-31
MVU QIAGEN [QIAGEN Sciences LLC]	HPV 18 Probe ASR	2006-10-31
MVU QIAGEN [QIAGEN Sciences LLC]	HPV 16 Probe ASR	2006-10-31
KXG QIAGEN [QIAGEN Sciences LLC]	digene? Female Swab Specimen Collection Kit	2003-04-16
JQW QIAGEN [QIAGEN Sciences LLC]	Rapid Capture? System (RCS)	2001-10-25
JJQ QIAGEN [QIAGEN Sciences LLC]	DML 2000	1996-06-13

Similar & Related FDA Registered Companies

• QIAGEN Sciences LLC
• QIAGEN Lake Constance GmbH
• QIAGEN Manchester Ltd
• QIAGEN, GmbH
• QIAGEN, Inc.
• 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
• QIAGEN GAITHERSBURG, INC
• QIAGEN SCIENCES INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020043024788	Rotterdam,Netherlands -> Norfolk, Virginia	MATERIAL FROM LABORATORY REAGENTS FILTER ELEM ENTS BUFFER AND SERVICE PACKAGES IN NEED OF D NA RNA INSULATION LOADED ONTO 20 PALLETS HS CODES 392690 392330 847990 392350 391990 842129 382200 285390	92 CTN
2020041531938	Rotterdam,Netherlands -> Norfolk, Virginia	MATERIAL FROM LABORATORY REAGENTS FILTER ELEM ENTS BUFFER AND SERVICE PACKAGES IN NEED OF D NA RNA INSULATION LOADED ONTO 20 PALLETS HS CODES 382200 392690 842129 847982 847990	120 CTN
2020040736732	Rotterdam,Netherlands -> Norfolk, Virginia	MATERIAL FROM LABORATORY REAGENTS, FILTER ELEMENTS, BUFFER AND SERVICE PACKAGES IN NEED OF DNA/RNA INSULATION	85 CTN
2020033134811	Rotterdam,Netherlands -> Norfolk, Virginia	MATERIAL FROM LABORATORY REAGENTS FILTER ELEM ENTS BUFFER AND SERVICE PACKAGES IN NEED OF D NA RNA INSULATION LOADED ONTO 20 PALLETS HS CODES 382200 392690 842129 847982 285390 847990 392330	104 CTN
2020032530536	Rotterdam,Netherlands -> Norfolk, Virginia	MATERIAL FROM LABORATORY REAGENTS FILTER ELEM ENTS BUFFER AND SERVICE PACKAGES IN NEED OF D NA RNA INSULATION LOADED ONTO 10 PALLETS HS CODES 847990 392690	104 CTN
2020032530536	Rotterdam,Netherlands -> Norfolk, Virginia	MATERIAL FROM LABORATORY REAGENTS FILTER ELEM ENTS BUFFER AND SERVICE PACKAGES IN NEED OF D NA RNA INSULATION LOADED ONTO 21 PALLETS HS CODES 847990 392690 392330 842129 392350	104 CTN
2020032021231	Rotterdam,Netherlands -> Norfolk, Virginia	MATERIAL FROM LABORATORY REAGENTS FILTER ELEM ENTS BUFFER AND SERVICE PACKAGES IN NEED OF D NA RNA INSULATION LOADED ONTO 20 PALLETS HS CODES 382200 392690 842129 847982 285390 392350 392330 847990	115 CTN
2020031321717	Rotterdam,Netherlands -> Norfolk, Virginia	MATERIAL FROM LABORATORY REAGENTS FILTER ELEM ENTS BUFFER AND SERVICE PACKAGES IN NEED OF D NA RNA INSULATION LOADED ONTO 10 PALLETS HS CODES 392690 847990	125 CTN
2020031321717	Rotterdam,Netherlands -> Norfolk, Virginia	MATERIAL FROM LABORATORY REAGENTS FILTER ELEM ENTS BUFFER AND SERVICE PACKAGES IN NEED OF D NA RNA INSULATION LOADED ONTO 21 PALLETS HS CODES 842129 392330 392350 392690 847990	125 CTN
2020030620815	Rotterdam,Netherlands -> Norfolk, Virginia	MATERIAL FROM LABORATORY REAGENTS FILTER ELEM ENTS BUFFER AND SERVICE PACKAGES IN NEED OF D NA RNA INSULATION LOADED ONTO 20 PALLETS HS CODES 382200 392690 842129 847982 285390 847990 392330	141 CTN