Qiagen Sciences L L C

FDA Filings

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

Qiagen Sciences L L C 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 Filings

Device
Company
DeviceDate
QIAGEN [QIAGEN Sciences LLC]
PartoSure Test2018-05-23
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 [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 [QIAGEN Sciences LLC]
digene? HPV Genotyping PS Test2013-09-12
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

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092333378Stadersand,Federal Republic of Germany -> Baltimore, MarylandGUANIDIE THIOCYANATE ULTRAPURE GUANIDINE HYR OCHLORIDE HS CODE 29252900 INV 102399 UN1759 CORROSIVE SOLID N.O.S. GUANIDINE THIOCYANETE IMO CLASS 8 III 250 PLASTIC DRUMS350 PCS
2020092248404Stadersand,Federal Republic of Germany -> Baltimore, MarylandGUANIDIE THIOCYANATE ULTRAPURE GUANIDINE HYR OCHLORIDE HS CODE 29252900 INV 102399 UN1759 CORROSIVE SOLID N.O.S. GUANIDINE THIOCYANETE IMO CLASS 8 III 250 PLASTIC DRUMS350 PCS
2020091947399Stadersand,Federal Republic of Germany -> Baltimore, MarylandPHARMACEUTICALS954 CTN
2020082735544Bremerhaven,Federal Republic of Germany -> Baltimore, MarylandLABORATORY EQUIPMENTHS CODE:8479907024 PKG
2020082444571Bremerhaven,Federal Republic of Germany -> Baltimore, MarylandLABORATORY EQUIPMENTHS CODE:8479907024 PKG
2020082148885Bremerhaven,Federal Republic of Germany -> Baltimore, MarylandLABORATORY EQUIPMENTHS CODE:8479907024 PKG
2020082060529Bremerhaven,Federal Republic of Germany -> Baltimore, MarylandLABORATORY EQUIPMENTHS CODE:8479907024 PKG
2019101047000Kaohsiung,China (Taiwan) -> Los Angeles, CaliforniaPLASTIC BAG INTERNATIONAL PLASTICS-C-AMIN33-10 BLUE CLEAR 3-SIDE SEALED BAG WITH LASER SCORE AND VENT HOLE HS CODE:3923291 CTN
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