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Qiagen Gaithersburg, Inc.

38 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
DML 3000 Microplate Luminometer, 5000-00031, digene® HC2 High-Risk HPV DNA Test (I plate), 5199-1220, digene® HC2 High-R (P890064/S042)Qiagen Gaithersburg, Inc.2023-10-19
digene HC2 High-Risk HPV DNA Test and digene HC2 HPV DNA Test (P890064/S041)Qiagen Gaithersburg, Inc.2020-06-18
HC2 High-Risk HPV DNA Test and digene / HC2 HPV DNA Test (P890064/S040)Qiagen Gaithersburg, Inc.2018-03-27
digene HC2 High-Risk HPV DNA Test and digene HC2 HPV DNA Test (P890064/S039)Qiagen Gaithersburg, Inc.2018-03-16
digene HC2 High-Risk HPB DNA Test and digene HC2 HPV DNA Test (P890064/S038)Qiagen Gaithersburg, Inc.2018-03-14
digene HC2 High-Risk HPV DNA Test and digene HC2 HPV DNA Test (P890064/S037)Qiagen Gaithersburg, Inc.2018-02-21
digene Hybird Capture 2 (HC2) HPV DNA Test (P890064/S036)Qiagen Gaithersburg, Inc.2018-02-08
Digene HC2 HPV DNA Test / Digene HC2 High Risk HPV DNA Test (P890064/S035)Qiagen Gaithersburg, Inc.2017-12-21
digene HC2 High Risk HPV DNA Test (P890064/S034)Qiagen Gaithersburg, Inc.2017-07-25
digene Hybrid Capture 2 (HC2) HPV DNA Test and digene Hybrid Capture 2 (HC2) High Risk (P890064/S033)Qiagen Gaithersburg, Inc.2016-04-15
DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TESTS (P890064/S032)Qiagen Gaithersburg, Inc.2015-05-29
DIGENE HC2 SYSTEM SOFTWARE (P890064/S031)Qiagen Gaithersburg, Inc.2014-10-09
DIGENE HC2 STSTEM SOFTWARE (P890064/S030)Qiagen Gaithersburg, Inc.2014-05-12
DIGENE HC2 HIGH RISK HPV DNA TEST AND DIGENE HC2 HPV DNA TEST (P890064/S029)Qiagen Gaithersburg, Inc.2014-04-14
DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST & DIGENE HYBRID CAPTURE 2 (HC2) HIGH RISK HPV DNA TEST (P890064/S027)Qiagen Gaithersburg, Inc.2012-05-21
DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST & DIGENE HYBRID CAPTURE CAPTURE 2 (HC2) HIGH HPV DNA TEST (P890064/S026)Qiagen Gaithersburg, Inc.2011-04-20
DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST & HIGH RISK HPV DNA TEST (P890064/S025)Qiagen Gaithersburg, Inc.2011-03-29
DIGENE HYBRID CAPTURE 2 (HC2) HPV DAN TEST (P890064/S024)Qiagen Gaithersburg, Inc.2010-05-17
DIGENE HYBRID CAPTURE 2 (HC2) HPV DAN TEST (P890064/S022)Qiagen Gaithersburg, Inc.2010-05-17
DIGENE HYBRID CAPTURE 2 (HC2) HPV DAN TEST (P890064/S023)Qiagen Gaithersburg, Inc.2010-05-17
DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST AND DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST (P890064/S021)Qiagen Gaithersburg, Inc.2010-03-31
DIGENE HYBRID CAPTURE2 (P890064/S020)Qiagen Gaithersburg, Inc.2009-08-12
DIGENE HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST AND DIGENE HYBRID CAPTURE 2 HPV DNA TEST (P890064/S018)Qiagen Gaithersburg, Inc.2006-04-28
DIGENE HYBRID CAPTURE HPV DNA TEST (P890064/S017)Qiagen Gaithersburg, Inc.2004-12-14
DIGENE HYBRID CAPTURE 2 HPV DNA TEST (P890064/S015)Qiagen Gaithersburg, Inc.2004-07-29
DIGENE HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST (P890064/S014)Qiagen Gaithersburg, Inc.2004-05-04
HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST AND HYBRID CAPTURE HPV DNA TEST (P890064/S013)Qiagen Gaithersburg, Inc.2003-11-07
DIGENE HYBRID CAPTURE 2 HPV DNA TEST (P890064/S012)Qiagen Gaithersburg, Inc.2003-06-20
DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST (P890064/S009)Qiagen Gaithersburg, Inc.2003-03-31
HCS HPV, HCII HPV (P890064/S008)Qiagen Gaithersburg, Inc.2000-09-12
DIGENE HYBRID CAPTURE II HIGH-RISK HPV DNA TEST (P890064/S007)Qiagen Gaithersburg, Inc.2000-03-16
HCII HPV TEST (DIGENE HPV TEST USING HYBRID CAPTURE II TECHNOLOGY) (P890064/S006)Qiagen Gaithersburg, Inc.1999-03-17
HYBRID CAPTURE(TM) SYSTEM HPV DNA ASSAY (P890064/S005)Qiagen Gaithersburg, Inc.1997-08-15
HYBRID CAPTURE(TM) SYSTEM HPV DNA ASSAY (P890064/S004)Qiagen Gaithersburg, Inc.1996-08-28
HYBRID CAPTURE(TM) SYSTEM VIRATYPE(R) PLUS HPV DNA (P890064/S003)Qiagen Gaithersburg, Inc.1995-04-28
VIRATYPE HUMAN PAPILLOMAVIRUS DNA TYPING KIT (P890064/S002)Qiagen Gaithersburg, Inc.1994-05-19
VIRATYPE HUMAN PAPILLOMAVIRUS DNA TYPING KIT (P890064/S001)Qiagen Gaithersburg, Inc.1993-05-17
VIRATYPE HUMAN PAPILLOMAVIRUS DNA TYPING KIT (P890064)Qiagen Gaithersburg, Inc.1991-03-11

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Every clearance here is in the API, with alerts when new ones post.