OraSure Technologies, Inc

FDA Filings

This page includes the latest FDA filings for OraSure Technologies, Inc. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
ORASURE TECHNOLOGIES, INC.
HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME2003-03-20
ORASURE TECHNOLOGIES, INC.
OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I2002-04-17
ORASURE TECHNOLOGIES, INC.
INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX2001-06-06
ORASURE TECHNOLOGIES, INC.
STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I2001-01-26
ORASURE TECHNOLOGIES, INC.
STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I2000-12-06
ORASURE TECHNOLOGIES, INC.
STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 114212000-11-29
ORASURE TECHNOLOGIES, INC.
STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 115412000-05-15
ORASURE TECHNOLOGIES, INC.
COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA2000-05-11
ORASURE TECHNOLOGIES, INC.
STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I2000-04-03
ORASURE TECHNOLOGIES, INC.
STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103I2000-04-03
ORASURE TECHNOLOGIES, INC.
HISTOFREEZER DEVICE1999-06-14
ORASURE TECHNOLOGIES, INC.
AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U1998-11-20
ORASURE TECHNOLOGIES, INC.
AUTO-LYTE BARBITURATES EIA1998-11-18
ORASURE TECHNOLOGIES, INC.
AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U1998-11-12
ORASURE TECHNOLOGIES, INC.
AUTO-LYTE PCP EIA, MODEL #1254U1998-11-04
ORASURE TECHNOLOGIES, INC.
HISTOFREEZER DEVICE1998-10-02
ORASURE TECHNOLOGIES, INC.
STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)1998-08-25
ORASURE TECHNOLOGIES, INC.
HISTOFREEZER/ 17% SALICYLIC ACID-VERRUCA PLANTARIS1998-05-26
ORASURE TECHNOLOGIES, INC.
STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION)1998-05-22
ORASURE TECHNOLOGIES, INC.
MICRO-PLATE COTININE EIA1998-05-18
ORASURE TECHNOLOGIES, INC.
MICRO-PLATE COTININE EIA1998-05-14
ORASURE TECHNOLOGIES, INC.
STC CANNABINOIDS MICRO-PLATE EIA1998-02-13
ORASURE TECHNOLOGIES, INC.
STC METHAMPHETAMINE MICRO-PLATE EIA1998-01-28
ORASURE TECHNOLOGIES, INC.
STC COCAINE METABOLITE MICRO-PLATE EIA1998-01-02
ORASURE TECHNOLOGIES, INC.
HISTOFREEZER VERRUCA PLANA1997-10-21
ORASURE TECHNOLOGIES, INC.
AUTO-LYTE COTININE EIA1997-10-21
ORASURE TECHNOLOGIES, INC.
Stc Auto-lyte Urinary Glucose Assay1996-12-26

Latest Premarket Applications

PMAManufacturerDevice NameDate
ORASURE TECHNOLOGIES INC.
OraQuick HCV Rapid Antibody Test2019-09-11
ORASURE TECHNOLOGIES INC.
OraQuick HCV Rapid Antibody Test2018-12-06
ORASURE TECHNOLOGIES INC.
OraQuick HCV Rapid Antibody Test2018-04-12
ORASURE TECHNOLOGIES INC.
OraQuick HCV Rapid Antibody Test2018-02-01
ORASURE TECHNOLOGIES INC.
OraQuick HCV Rapid Antibody Test2018-01-03
ORASURE TECHNOLOGIES INC.
OraQuick HCV Rapid Antibody Test2017-09-27
ORASURE TECHNOLOGIES INC.
OraQuick HCV Rapid Antibody Test2017-09-07
ORASURE TECHNOLOGIES INC.
OraQuick HCV Antibody Test2017-06-30
ORASURE TECHNOLOGIES INC.
OraQuick HCV Rapid Antibody Test2017-05-11
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST2017-02-28
ORASURE TECHNOLOGIES INC.
OraQuick HCV Rapid Antibody Test2016-12-15
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST2016-11-18
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST2016-05-10
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST2016-02-20
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST2015-10-15
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST2015-01-28
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST2014-10-02
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST2014-09-02
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST2014-07-11
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST2013-12-17
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST2013-10-03
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST2013-09-26
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST2013-08-01
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST2013-05-28
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST2013-03-21
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST2013-03-19
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST2013-01-24
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST2012-12-17
ORASURE TECHNOLOGIES INC.
ORAQUICK RAPID HCV ANTIBODY2011-10-20
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST2011-07-27

Latest De Novo Filings

De NovoManufacturerDevice NameDate
OraSure Technologies, Inc.
OraQuick Ebola Rapid Antigen Test2019-10-10

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
OraQuick Ebola Rapid Antigen Test
Orasure Technologies, Inc.2020-03-09
OraSure HIV-1 Western Blot Kit
Orasure Technologies, Inc.2018-09-14
Q.E.D. Saliva Alcohol Test A150
Orasure Technologies, Inc.2018-07-06
OraQuick In Home HIV Test, Pharmacy
Orasure Technologies, Inc.2018-07-06
PCP Intercept 2 Plate Kit
Orasure Technologies, Inc.2018-07-06
PCP Intercept 100 Plate Kit
Orasure Technologies, Inc.2018-07-06
PCP Intercept 5 Plate Kit
Orasure Technologies, Inc.2018-07-06
Opiates Intercept 100 Plate Kit
Orasure Technologies, Inc.2018-07-06
Opiates Intercept 5 Plate Kit
Orasure Technologies, Inc.2018-07-06
Opiates Serum 2 Plate Kit
Orasure Technologies, Inc.2018-07-06
Opiates Serum 5 plate Kit
Orasure Technologies, Inc.2018-07-06
Cotinine OraSure 100 Plate Kit
Orasure Technologies, Inc.2018-07-06
Cotinine OraSure 5 Plate Kit
Orasure Technologies, Inc.2018-07-06
OraSure Quick Flu 22-Count Flu A + B Kit
Orasure Technologies, Inc.2018-07-06
OraQuick HCV Rapid Antibody Test Kit Controls
Orasure Technologies, Inc.2018-07-06
OraQuick HCV Rapid Antibody Test
Orasure Technologies, Inc.2018-07-06
Auto-Lyte
Orasure Technologies, Inc.2018-07-06
Cocaine OraSure 100 Plate Kit
Orasure Technologies, Inc.2018-07-06
Cocaine OraSure 5 Plate Kit
Orasure Technologies, Inc.2018-07-06
Cotinine Serum 2 Plate Kit
Orasure Technologies, Inc.2018-07-06
Cotinine Serum 5 Plate Kit
Orasure Technologies, Inc.2018-07-06
Methadone Intercept 2 Plate Kit
Orasure Technologies, Inc.2018-07-06
Methadone Intercept 100 Plate Kit
Orasure Technologies, Inc.2018-07-06
Methadone Intercept 5 Plate Kit
Orasure Technologies, Inc.2018-07-06
Cocaine Intercept 2 Plate Kit
Orasure Technologies, Inc.2018-07-06
Cocaine Intercept 100 Plate Kit
Orasure Technologies, Inc.2018-07-06
Cocaine Intercept 5 Plate Kit
Orasure Technologies, Inc.2018-07-06
Cannabinoids Intercept 2 Plate Kit
Orasure Technologies, Inc.2018-07-06
Cannabinoids Intercept 100 Plate Kit
Orasure Technologies, Inc.2018-07-06
Cannabinoids Intercept 5 Plate Kit
Orasure Technologies, Inc.2018-07-06
Benzodiazepine Intercept 2 Plate Kit
Orasure Technologies, Inc.2018-07-06
Benzodiazepine Intercept 100 Plate Kit
Orasure Technologies, Inc.2018-07-06
Benzodiazepine Intercept 5 Plate Kit
Orasure Technologies, Inc.2018-07-06
Barbiturates Intercept 2 Plate Kit
Orasure Technologies, Inc.2018-07-06
Barbiturates Intercept 100 Plate Kit
Orasure Technologies, Inc.2018-07-06

Related Finance Registrations
ORASURE TECHNOLOGIES INC of DELAWARE0001116463
Legal Entity Identifier 529900GNNJPNM4XHXQ77 [OraSure Technologies, Inc.]

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