ORASURE TECHNOLOGIES INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3004142665	3004142665	ORASURE TECHNOLOGIES INC.	1	N	2027-01-01	220 EAST FIRST STREET BETHLEHEM PA US 18015

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
11685	1451668060	P080027	ORAQUICK HCV RAPID ANTIBODY TEST	MZO	2010-06-25
11685	2018765012	K993208	STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I	LAF	2000-04-03
11685	1120365358	K992918	STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103I	DKZ	2000-04-03
11685	1123585146	K982831	AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U	JXM	1998-11-12
11685	1001430019	K982801	AUTO-LYTE PCP EIA, MODEL #1254U	LCM	1998-11-04
11685	1643437115	K982759	AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U	DIO	1998-11-20
11685	1841884229	K982061	STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)	DIO	1998-08-25
11685	2042852518	K981341	STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION)	DJG	1998-05-22
11685	1624928550	K974234	MICRO-PLATE COTININE EIA	MKU	1998-05-14
11685	1523463735	K970357	EPISCREEN	PJD	1997-03-10
11685	1650792783	K083746	BIOSIGN FLU A+B	PSZ	2010-11-10
11685	1414411589	K023487	HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME	GEH	2003-03-20
11685	1531335080	K013882	OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I	JXM	2002-04-17
11685	1897000117	K011057	INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX	PJD	2001-06-06
11685	1887009359	K002010	STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421	DJR	2000-11-29
11685	1956111218	DEN190025	OraQuick Ebola Rapid Antigen Test	QID	2019-10-10
11685	1717835327	BP950004
11685	2016193288	BP910001
11685	1708853313	BP120001
11685	1046624333	BP010047
11685	1229218134
11685	1278609373
11685	1536384484
11685	1607344736
11685	1680089497
11685	2031241003

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
JXM	2	2002-04-17
PJD	2	2001-06-06
DIO	2	1998-11-20
QID	1	2019-10-10
PSZ	1	2010-11-10
MZO	1	2010-06-25
GEH	1	2003-03-20
DJR	1	2000-11-29
DKZ	1	2000-04-03
LAF	1	2000-04-03
LCM	1	1998-11-04
DJG	1	1998-05-22
MKU	1	1998-05-14

PMA#

OraQuick HCV Rapid Antibody Test
2021-04-20
ORASURE TECHNOLOGIES INC.
OraQuick HCV Rapid Antibody Test
2021-02-25
ORASURE TECHNOLOGIES INC.
OraQuick HCV Rapid Antibody Test
2020-10-16
ORASURE TECHNOLOGIES INC.
OraQuick HCV Rapid Antibody Test
2019-09-11
ORASURE TECHNOLOGIES INC.
OraQuick HCV Rapid Antibody Test
2018-12-06
ORASURE TECHNOLOGIES INC.
OraQuick HCV Rapid Antibody Test
2018-04-12
ORASURE TECHNOLOGIES INC.
OraQuick HCV Rapid Antibody Test
2018-02-01
ORASURE TECHNOLOGIES INC.
OraQuick HCV Rapid Antibody Test
2018-01-03
ORASURE TECHNOLOGIES INC.
OraQuick HCV Rapid Antibody Test
2017-09-27
ORASURE TECHNOLOGIES INC.
OraQuick HCV Rapid Antibody Test
2017-09-07
ORASURE TECHNOLOGIES INC.
OraQuick HCV Antibody Test
2017-06-30
ORASURE TECHNOLOGIES INC.
OraQuick HCV Rapid Antibody Test
2017-05-11
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST
2017-02-28
ORASURE TECHNOLOGIES INC.
OraQuick HCV Rapid Antibody Test
2016-12-15
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST
2016-11-18
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST
2016-05-10
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST
2016-02-20
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST
2015-10-15
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST
2015-01-28
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST
2014-10-02
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST
2014-09-02
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST
2014-07-11
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST
2013-12-17
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST
2013-10-03
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST
2013-09-26
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST
2013-08-01
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST
2013-05-28
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST
2013-03-21
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST
2013-03-19
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST
2013-01-24
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST
2012-12-17
ORASURE TECHNOLOGIES INC.
ORAQUICK RAPID HCV ANTIBODY
2011-10-20
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST
2011-07-27
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST
2011-05-04
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST
2011-02-18
ORASURE TECHNOLOGIES INC.
ORAQUICK HCV RAPID ANTIBODY TEST
2010-06-25
ORASURE TECHNOLOGIES INC.