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:

FDA Registration(s)
Registration Number1122376
FEI Number3003572099
NameQIAGEN
Owner & OperatorQIAGEN Sciences LLC
Contact Address19300 Germantown Road --
Germantown MD 20874 US
Official Correspondent
  • Lindsey - Howard
  • x-240-6867826-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address19300 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
DeviceDate
QIAGEN
QuantiFERON®-TB Gold, QuantiFERON®-TB Gold Plus2021-12-13
QIAGEN
QuantiFERON – TB Gold and QuantiFERON-TB Gold Plus2019-12-06
QIAGEN
Quantiferon - TB Gold Plus Test2019-04-29
QIAGEN
QuantiFERON- TB Gold Test and QuantiFERON- TB Gold Plus Test2019-04-29
QIAGEN
TB Gold and QuantiFERON - TB Gold Plus2019-03-15
QIAGEN
QuantiFERON - TB Gold Test, QuantiFERON - TB Gold Plus Test2019-01-04
QIAGEN
QuantiFERON-TB Gold Test / QuantiFERON TB Gold Plus Test2018-10-30
QIAGEN
QuantiFERON TB Gold Test, QuantiFERON TB Gold Test (reference lab pack), QuantiFERON TB Gold Plus Test, QuantiFERON TB G2018-10-04
QIAGEN
QuantiFeron TB Gold and QuantiFeron TB Gold Plus2018-08-24
QIAGEN [QIAGEN Sciences LLC]
PartoSure Test2018-05-23
QIAGEN
QuantiFERON-TB Gold and QuantiFERON-TB Gold Plus2018-03-27
QIAGEN
QuantiFeron TB Gold and QuantiFeron TB Gold Plus2018-02-23
QIAGEN
QuantiFERON-TB Gold and QuantiFERON -TB Gold Plus.2017-12-07
QIAGEN
QuantiFERON - TB Gold Test and TB Gold Plus Test2017-11-21
QIAGEN
Quantiferon TB Gold2017-06-20
QIAGEN
QUANTTFERON-TB GOLD Plus2017-06-07
QIAGEN
QUANTTFERON-TB Gold2017-05-09
QIAGEN
QuantiFERON-TB GOLD Test2017-03-07
QIAGEN [QIAGEN Sciences LLC]
AmniSure ROM Test Positive and Negative Controls Pack2016-11-30
QIAGEN [QIAGEN Sciences LLC]
AmniSure ROM Test Positive and Negative Controls Pack2016-11-30
QIAGEN
QUANTIFERON-TB GOLD AND TB GOLD- Test (reference lab pack)2016-08-25
QIAGEN
QUANTIFERON-TB GOLD AND TB GOLD Test (reference lab pack)2016-08-19
QIAGEN
QUANTTFERON-TB GOLD AND TB GOLD-IN-THE-TUBE2016-04-27
QIAGEN [QIAGEN Sciences LLC]
AmniSure? ROM (Rupture of [fetal] Membranes) Test2015-08-18
QIAGEN [QIAGEN Sciences LLC]
QuantiFeron?-TB Gold Test2015-05-28
QIAGEN [QIAGEN Sciences LLC]
QuantiFeron?-TB Gold Plus Test2015-05-28
QIAGEN
Artus HSV-1/2 QS-RGQ MDx Kit2014-12-19
QIAGEN
QUANTIFERON-TB GOLD TEST2014-12-10
QIAGEN
QUANTIFERON- TB GOLD TEST2014-12-04
QIAGEN
QUANTIFERON TB GOLD IN-TUBE2014-05-22
QIAGEN
QUANTIFERON -TB GOLD2014-01-31
QIAGEN [QIAGEN Sciences LLC]
digene? HPV Genotyping PS Test2013-09-12
QIAGEN
QUANTIFERON -TB GOLD2012-11-15
QIAGEN
QUANTIFERON -TB GOLD2011-10-20
QIAGEN
QUANTIFERON-TB GOLD2011-08-23
QIAGEN
QUANTIFERON-TB GOLD IN-TUBE2011-05-26
QIAGEN
QUANTIFERON-TB GOLD IN-TUBE2010-12-17
QIAGEN [QIAGEN Sciences LLC]
Wash Buffer X 152009-10-09
QIAGEN [QIAGEN Sciences LLC]
Probe Diluent2009-10-09
QIAGEN [QIAGEN Sciences LLC]
Indicator Dye2009-10-09
QIAGEN [QIAGEN Sciences LLC]
Detection Reagent 22009-10-09
QIAGEN [QIAGEN Sciences LLC]
Detection Reagent 12009-10-09
QIAGEN [QIAGEN Sciences LLC]
DNR2009-10-09
QIAGEN [QIAGEN Sciences LLC]
5.5% NP-402009-10-09
QIAGEN [QIAGEN Sciences LLC]
HPV Positive Control 22009-10-09
QIAGEN [QIAGEN Sciences LLC]
HPV Positive Control 12009-10-09
QIAGEN [QIAGEN Sciences LLC]
HPV Negative Control 22009-10-09
QIAGEN [QIAGEN Sciences LLC]
HPV Negative Control 12009-10-09
QIAGEN [QIAGEN Sciences LLC]
digene? HC2 High-Risk HPV DNA Test2008-05-02
QIAGEN [QIAGEN Sciences LLC]
digene? HC2 High-Risk HPV DNA Test (4 plate)2008-05-02
QIAGEN [QIAGEN Sciences LLC]
digene? HC2 HPV DNA Test2008-05-02
QIAGEN [QIAGEN Sciences LLC]
DML 30002008-05-02
QIAGEN [QIAGEN Sciences LLC]
digene? HC2 CT/GC DNA Test, Version 22008-05-02
QIAGEN [QIAGEN Sciences LLC]
digene? HC2 CT-ID DNA Test, Version 22008-05-02
QIAGEN [QIAGEN Sciences LLC]
digene? HC2 CT-GC Dual-ID DNA Test, Version 22008-05-02
QIAGEN [QIAGEN Sciences LLC]
digene? HC2 GC-ID DNA Test, Version 22008-05-02
QIAGEN [QIAGEN Sciences LLC]
digene? HC2 CT/GC DNA Test, Version 22008-05-02
QIAGEN [QIAGEN Sciences LLC]
digene? HC2 CT-GC Dual-ID DNA Test, Version 22008-05-02
QIAGEN [QIAGEN Sciences LLC]
digene? HC2 DNA Collection Device2008-05-02
QIAGEN [QIAGEN Sciences LLC]
Lyophilized R8482006-10-31
QIAGEN [QIAGEN Sciences LLC]
Lyophilized Anti-CD32006-10-31
QIAGEN [QIAGEN Sciences LLC]
HPV 45 Probe ASR2006-10-31
QIAGEN [QIAGEN Sciences LLC]
HPV 18 Probe ASR2006-10-31
QIAGEN [QIAGEN Sciences LLC]
HPV 16 Probe ASR2006-10-31
QIAGEN [QIAGEN Sciences LLC]
digene? Female Swab Specimen Collection Kit2003-04-16
QIAGEN [QIAGEN Sciences LLC]
Rapid Capture? System (RCS)2001-10-25
QIAGEN [QIAGEN Sciences LLC]
DML 20001996-06-13

Similar & Related FDA Registered Companies

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020043024788Rotterdam,Netherlands -> Norfolk, VirginiaMATERIAL 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 28539092 CTN
2020041531938Rotterdam,Netherlands -> Norfolk, VirginiaMATERIAL 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 847990120 CTN
2020040736732Rotterdam,Netherlands -> Norfolk, VirginiaMATERIAL FROM LABORATORY REAGENTS, FILTER ELEMENTS, BUFFER AND SERVICE PACKAGES IN NEED OF DNA/RNA INSULATION85 CTN
2020033134811Rotterdam,Netherlands -> Norfolk, VirginiaMATERIAL 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 392330104 CTN
2020032530536Rotterdam,Netherlands -> Norfolk, VirginiaMATERIAL FROM LABORATORY REAGENTS FILTER ELEM ENTS BUFFER AND SERVICE PACKAGES IN NEED OF D NA RNA INSULATION LOADED ONTO 10 PALLETS HS CODES 847990 392690104 CTN
2020032530536Rotterdam,Netherlands -> Norfolk, VirginiaMATERIAL 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 392350104 CTN
2020032021231Rotterdam,Netherlands -> Norfolk, VirginiaMATERIAL 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 847990115 CTN
2020031321717Rotterdam,Netherlands -> Norfolk, VirginiaMATERIAL FROM LABORATORY REAGENTS FILTER ELEM ENTS BUFFER AND SERVICE PACKAGES IN NEED OF D NA RNA INSULATION LOADED ONTO 10 PALLETS HS CODES 392690 847990125 CTN
2020031321717Rotterdam,Netherlands -> Norfolk, VirginiaMATERIAL 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 847990125 CTN
2020030620815Rotterdam,Netherlands -> Norfolk, VirginiaMATERIAL 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 392330141 CTN

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