Qiagen Gaithersburg Inc

FDA Filings

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

FDA Filings

Device Company	Device	Date
PMA P890064S041 QIAGEN GAITHERSBURG, INC	digene HC2 High-Risk HPV DNA Test and digene HC2 HPV DNA Test	2020-06-18
PMA P890064S040 QIAGEN GAITHERSBURG, INC	HC2 High-Risk HPV DNA Test and digene / HC2 HPV DNA Test	2018-03-27
PMA P890064S039 QIAGEN GAITHERSBURG, INC	digene HC2 High-Risk HPV DNA Test and digene HC2 HPV DNA Test	2018-03-16
PMA P890064S038 QIAGEN GAITHERSBURG, INC	digene HC2 High-Risk HPB DNA Test and digene HC2 HPV DNA Test	2018-03-14
PMA P890064S037 QIAGEN GAITHERSBURG, INC	digene HC2 High-Risk HPV DNA Test and digene HC2 HPV DNA Test	2018-02-21
PMA P890064S036 QIAGEN GAITHERSBURG, INC	digene Hybird Capture 2 (HC2) HPV DNA Test	2018-02-08
PMA P890064S035 QIAGEN GAITHERSBURG, INC	Digene HC2 HPV DNA Test / Digene HC2 High Risk HPV DNA Test	2017-12-21
PMA P890064S034 QIAGEN GAITHERSBURG, INC	digene HC2 High Risk HPV DNA Test	2017-07-25
PMA P890064S033 QIAGEN GAITHERSBURG, INC	digene Hybrid Capture 2 (HC2) HPV DNA Test and digene Hybrid Capture 2 (HC2) High Risk	2016-04-15
PMA P890064S032 QIAGEN GAITHERSBURG, INC	DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TESTS	2015-05-29
PMA P890064S031 QIAGEN GAITHERSBURG, INC	DIGENE HC2 SYSTEM SOFTWARE	2014-10-09
PMA P890064S030 QIAGEN GAITHERSBURG, INC	DIGENE HC2 STSTEM SOFTWARE	2014-05-12
PMA P890064S029 QIAGEN GAITHERSBURG, INC	DIGENE HC2 HIGH RISK HPV DNA TEST AND DIGENE HC2 HPV DNA TEST	2014-04-14
PMA P890064S027 QIAGEN GAITHERSBURG, INC	DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST & DIGENE HYBRID CAPTURE 2 (HC2) HIGH RISK HPV DNA TEST	2012-05-21
PMA P890064S026 QIAGEN GAITHERSBURG, INC	DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST & DIGENE HYBRID CAPTURE CAPTURE 2 (HC2) HIGH HPV DNA TEST	2011-04-20
PMA P890064S025 QIAGEN GAITHERSBURG, INC	DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST & HIGH RISK HPV DNA TEST	2011-03-29
PMA P890064S024 QIAGEN GAITHERSBURG, INC	DIGENE HYBRID CAPTURE 2 (HC2) HPV DAN TEST	2010-05-17
PMA P890064S023 QIAGEN GAITHERSBURG, INC	DIGENE HYBRID CAPTURE 2 (HC2) HPV DAN TEST	2010-05-17
PMA P890064S022 QIAGEN GAITHERSBURG, INC	DIGENE HYBRID CAPTURE 2 (HC2) HPV DAN TEST	2010-05-17
PMA P890064S021 QIAGEN GAITHERSBURG, INC	DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST AND DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST	2010-03-31
PMA P890064S020 QIAGEN GAITHERSBURG, INC	DIGENE HYBRID CAPTURE2	2009-08-12
PMA P890064S018 QIAGEN GAITHERSBURG, INC	DIGENE HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST AND DIGENE HYBRID CAPTURE 2 HPV DNA TEST	2006-04-28
PMA P890064S017 QIAGEN GAITHERSBURG, INC	DIGENE HYBRID CAPTURE HPV DNA TEST	2004-12-14
PMA P890064S015 QIAGEN GAITHERSBURG, INC	DIGENE HYBRID CAPTURE 2 HPV DNA TEST	2004-07-29
PMA P890064S014 QIAGEN GAITHERSBURG, INC	DIGENE HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST	2004-05-04
PMA P890064S013 QIAGEN GAITHERSBURG, INC	HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST AND HYBRID CAPTURE HPV DNA TEST	2003-11-07
PMA P890064S012 QIAGEN GAITHERSBURG, INC	DIGENE HYBRID CAPTURE 2 HPV DNA TEST	2003-06-20
PMA P890064S009 QIAGEN GAITHERSBURG, INC	DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST	2003-03-31
PMA P890064S008 QIAGEN GAITHERSBURG, INC	HCS HPV, HCII HPV	2000-09-12
PMA P890064S007 QIAGEN GAITHERSBURG, INC	DIGENE HYBRID CAPTURE II HIGH-RISK HPV DNA TEST	2000-03-16
PMA P890064S006 QIAGEN GAITHERSBURG, INC	HCII HPV TEST (DIGENE HPV TEST USING HYBRID CAPTURE II TECHNOLOGY)	1999-03-17
PMA P890064S005 QIAGEN GAITHERSBURG, INC	HYBRID CAPTURE(TM) SYSTEM HPV DNA ASSAY	1997-08-15
PMA P890064S004 QIAGEN GAITHERSBURG, INC	HYBRID CAPTURE(TM) SYSTEM HPV DNA ASSAY	1996-08-28
PMA P890064S003 QIAGEN GAITHERSBURG, INC	HYBRID CAPTURE(TM) SYSTEM VIRATYPE(R) PLUS HPV DNA	1995-04-28
PMA P890064S002 QIAGEN GAITHERSBURG, INC	VIRATYPE HUMAN PAPILLOMAVIRUS DNA TYPING KIT	1994-05-19
PMA P890064S001 QIAGEN GAITHERSBURG, INC	VIRATYPE HUMAN PAPILLOMAVIRUS DNA TYPING KIT	1993-05-17
PMA P890064 QIAGEN GAITHERSBURG, INC	VIRATYPE HUMAN PAPILLOMAVIRUS DNA TYPING KIT	1991-03-11

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020042419066	Stadersand,Federal Republic of Germany -> Baltimore, Maryland	LABORATORY EQUIPMENT	24 PKG
2019110223926	Bremerhaven,Federal Republic of Germany -> Baltimore, Maryland	ON 24 PALLETS MEDICAL SUPPLY HS CODE : 84799070	24 PKG
2019021830104	Bremerhaven,Federal Republic of Germany -> Baltimore, Maryland	ON 24 PALLETS MEDICAL SUPPLY HS CODE : 84799070	24 PKG
2019021545489	Bremerhaven,Federal Republic of Germany -> Baltimore, Maryland	ON 24 PALLETS MEDICAL SUPPLY HS CODE : 84799070	24 PKG
2018082041373	Bremerhaven,Federal Republic of Germany -> Baltimore, Maryland	ON 24 PALLETS PIPETTE TIPS	24 PKG