ORASURE TECHNOLOGIES, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3003297763	3003297763	ORASURE TECHNOLOGIES, INC.	1	N	2026-01-01	150 WEBSTER ST Bethlehem PA US 18015
3022474803	3022474803	ORASURE TECHNOLOGIES, INC.	1	N	2026-01-01	2685 Opus Way -- Bethlehem PA US 18020
2528909	2528909	ORASURE TECHNOLOGIES, INC.	1	N	2020-04-25	1745 EATON AVE. BETHLEHEM PA US 18018
3014512172	3014512172	OraSure Technologies, Inc.	1	Y	2020-04-25	2500 Emrick Blvd. Suite 100 Bethlehem PA US 18020

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00608337000047	OraSure Quickflu Nasopharyngeal Wash / Aspirate - 1001-0321	610-882-1820	customercare@orasure.com
00608337000054	OraSure QuickFlu Positive and Negative Control Kit - 1001-0323	610-882-1820	customercare@orasure.com

orasure.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
42145	1451668060	P080027	ORAQUICK HCV RAPID ANTIBODY TEST	MZO	2010-06-25
115187	1451668060	P080027	ORAQUICK HCV RAPID ANTIBODY TEST	MZO	2010-06-25
305166	1451668060	P080027	ORAQUICK HCV RAPID ANTIBODY TEST	MZO	2010-06-25
218464	1451668060	P080027	ORAQUICK HCV RAPID ANTIBODY TEST	MZO	2010-06-25
42145	2018765012	K993208	STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I	LAF	2000-04-03
218464	2018765012	K993208	STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I	LAF	2000-04-03
115187	2018765012	K993208	STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I	LAF	2000-04-03
42145	1120365358	K992918	STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103I	DKZ	2000-04-03
115187	1120365358	K992918	STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103I	DKZ	2000-04-03
218464	1120365358	K992918	STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103I	DKZ	2000-04-03
218464	1123585146	K982831	AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U	JXM	1998-11-12
218464	1001430019	K982801	AUTO-LYTE PCP EIA, MODEL #1254U	LCM	1998-11-04
42145	1643437115	K982759	AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U	DIO	1998-11-20
115187	1643437115	K982759	AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U	DIO	1998-11-20
218464	1643437115	K982759	AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U	DIO	1998-11-20
115187	1841884229	K982061	STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)	DIO	1998-08-25
218464	1841884229	K982061	STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)	DIO	1998-08-25
42145	1841884229	K982061	STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)	DIO	1998-08-25
42145	2042852518	K981341	STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION)	DJG	1998-05-22
115187	2042852518	K981341	STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION)	DJG	1998-05-22
218464	2042852518	K981341	STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION)	DJG	1998-05-22
42145	1808849595	K974534	MICRO-PLATE COTININE EIA	MKU	1998-05-18
115187	1808849595	K974534	MICRO-PLATE COTININE EIA	MKU	1998-05-18
218464	1808849595	K974534	MICRO-PLATE COTININE EIA	MKU	1998-05-18
115187	1624928550	K974234	MICRO-PLATE COTININE EIA	MKU	1998-05-14
218464	1624928550	K974234	MICRO-PLATE COTININE EIA	MKU	1998-05-14
115187	1598418634	K972481	AUTO-LYTE COTININE EIA	MKU	1997-10-21
218464	1598418634	K972481	AUTO-LYTE COTININE EIA	MKU	1997-10-21
218464	1523463735	K970357	EPISCREEN	PJD	1997-03-10
42145	1523463735	K970357	EPISCREEN	PJD	1997-03-10
115187	1523463735	K970357	EPISCREEN	PJD	1997-03-10
42145	1550870916	K924446	MICRO-PLATE OPIATES ASSAY	DJG	1992-10-15
115187	1550870916	K924446	MICRO-PLATE OPIATES ASSAY	DJG	1992-10-15
218464	1550870916	K924446	MICRO-PLATE OPIATES ASSAY	DJG	1992-10-15
42145	1179553217	K894001	SALIVA ALCOHOL TEST	DIC	1990-04-05
115187	1179553217	K894001	SALIVA ALCOHOL TEST	DIC	1990-04-05
218464	1179553217	K894001	SALIVA ALCOHOL TEST	DIC	1990-04-05
305166	1132411072	K192920	Oragene®•Dx	OYJ	2020-01-14
305166	1468694142	K152556	Oragene Dx	OYJ	2016-05-26
305166	1680089497	K152464	ORAcollect.Dx	OYJ	2016-05-26
305166	1607902791	K110701	ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500	OYJ	2011-12-02
42145	1650792783	K083746	BIOSIGN FLU A+B	PSZ	2010-11-10
115187	1650792783	K083746	BIOSIGN FLU A+B	PSZ	2010-11-10
218464	1650792783	K083746	BIOSIGN FLU A+B	PSZ	2010-11-10
42145	1414411589	K023487	HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME	GEH	2003-03-20
115187	1414411589	K023487	HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME	GEH	2003-03-20
218464	1414411589	K023487	HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME	GEH	2003-03-20
218464	1531335080	K013882	OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I	JXM	2002-04-17
115187	1531335080	K013882	OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I	JXM	2002-04-17
42145	1531335080	K013882	OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I	JXM	2002-04-17
42145	1897000117	K011057	INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX	PJD	2001-06-06
218464	1897000117	K011057	INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX	PJD	2001-06-06
115187	1897000117	K011057	INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX	PJD	2001-06-06
42145	1538018577	K002375	STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I	LDJ	2001-01-26
115187	1538018577	K002375	STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I	LDJ	2001-01-26
218464	1538018577	K002375	STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I	LDJ	2001-01-26
42145	1887009359	K002010	STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421	DJR	2000-11-29
115187	1887009359	K002010	STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421	DJR	2000-11-29
218464	1887009359	K002010	STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421	DJR	2000-11-29
42145	1935965166	K001976	STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I	DIS	2000-12-06
115187	1935965166	K001976	STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I	DIS	2000-12-06
218464	1935965166	K001976	STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I	DIS	2000-12-06
115187	2017106567	K001197	COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA	DIO	2000-05-11
218464	2017106567	K001197	COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA	DIO	2000-05-11
42145	2017106567	K001197	COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA	DIO	2000-05-11
42145	1341465966	K000399	STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541	LCM	2000-05-15
115187	1341465966	K000399	STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541	LCM	2000-05-15
218464	1341465966	K000399	STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541	LCM	2000-05-15
305166	2031241003	DEN200040	OMNIgene GUT Dx	QPO	2021-11-03
115187	1956111218	DEN190025	OraQuick Ebola Rapid Antigen Test	QID	2019-10-10
42145	1956111218	DEN190025	OraQuick Ebola Rapid Antigen Test	QID	2019-10-10
218464	1956111218	DEN190025	OraQuick Ebola Rapid Antigen Test	QID	2019-10-10
305166	1956111218	DEN190025	OraQuick Ebola Rapid Antigen Test	QID	2019-10-10
115187	1717835327	BP950004
218464	1717835327	BP950004
115187	2016193288	BP910001
218464	2016193288	BP910001
305166	2016193288	BP910001
115187	1708853313	BP120001
42145	1708853313	BP120001
218464	1708853313	BP120001
305166	1708853313	BP120001
305166	1046624333	BP010047
218464	1046624333	BP010047
115187	1046624333	BP010047
42145	1046624333	BP010047
42145	1229218134
115187	1229218134
218464	1229218134
115187	1536384484
305166	1536384484
305166	1607344736
305166	1612108058
115187	1851329796
305166	1851329796
305166	1938189830
305166	2005555730

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
DIO	9	2000-05-11
MKU	7	1998-05-18
PJD	6	2001-06-06
DJG	6	1998-05-22
OYJ	4	2020-01-14
QID	4	2019-10-10
MZO	4	2010-06-25
JXM	4	2002-04-17
LCM	4	2000-05-15
PSZ	3	2010-11-10
GEH	3	2003-03-20
LDJ	3	2001-01-26
DIS	3	2000-12-06
DJR	3	2000-11-29
DKZ	3	2000-04-03
LAF	3	2000-04-03
DIC	3	1990-04-05
QPO	1	2021-11-03

PMN#

COMPOUND W FREEZE OFF WART REMOVAL SYSTEM
2006-07-18
ORASURE TECHNOLOGIES, INC.
HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME
2003-03-20
ORASURE TECHNOLOGIES, INC.
OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I
2002-04-17
ORASURE TECHNOLOGIES, INC.
UPLINK TEST SYSTEM
2002-04-03
ORASURE TECHNOLOGIES, INC.
INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX
2001-06-06
ORASURE TECHNOLOGIES, INC.
STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I
2001-01-26
ORASURE TECHNOLOGIES, INC.
STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I
2000-12-06
ORASURE TECHNOLOGIES, INC.
STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421
2000-11-29
ORASURE TECHNOLOGIES, INC.
STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541
2000-05-15
ORASURE TECHNOLOGIES, INC.
COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA
2000-05-11
ORASURE TECHNOLOGIES, INC.
STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103I
2000-04-03
ORASURE TECHNOLOGIES, INC.
STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I
2000-04-03
ORASURE TECHNOLOGIES, INC.
HISTOFREEZER DEVICE
1999-06-14
ORASURE TECHNOLOGIES, INC.
AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U
1998-11-20
ORASURE TECHNOLOGIES, INC.
AUTO-LYTE BARBITURATES EIA
1998-11-18
ORASURE TECHNOLOGIES, INC.
AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U
1998-11-12
ORASURE TECHNOLOGIES, INC.
AUTO-LYTE PCP EIA, MODEL #1254U
1998-11-04
ORASURE TECHNOLOGIES, INC.
HISTOFREEZER DEVICE
1998-10-02
ORASURE TECHNOLOGIES, INC.
STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)
1998-08-25
ORASURE TECHNOLOGIES, INC.
HISTOFREEZER/ 17% SALICYLIC ACID-VERRUCA PLANTARIS
1998-05-26
ORASURE TECHNOLOGIES, INC.
STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION)
1998-05-22
ORASURE TECHNOLOGIES, INC.
MICRO-PLATE COTININE EIA
1998-05-18
ORASURE TECHNOLOGIES, INC.
MICRO-PLATE COTININE EIA
1998-05-14
ORASURE TECHNOLOGIES, INC.
STC CANNABINOIDS MICRO-PLATE EIA
1998-02-13
ORASURE TECHNOLOGIES, INC.
STC METHAMPHETAMINE MICRO-PLATE EIA
1998-01-28
ORASURE TECHNOLOGIES, INC.
STC COCAINE METABOLITE MICRO-PLATE EIA
1998-01-02
ORASURE TECHNOLOGIES, INC.
HISTOFREEZER VERRUCA PLANA
1997-10-21
ORASURE TECHNOLOGIES, INC.
AUTO-LYTE COTININE EIA
1997-10-21
ORASURE TECHNOLOGIES, INC.
STC AUTO-LYTE URINARY GLUCOSE ASSAY
1996-12-26
ORASURE TECHNOLOGIES, INC.

GUDID#

OraSure Oral Fluid Collection Device - 3001-2870
Orasure Technologies, Inc.
2019-02-15
Histofreezer - Histofreezer Kit, U.S., 60MC2 +10
Orasure Technologies, Inc.
2016-09-15
Histofreezer - Histofreezer Kit, U.S., 36M1C
Orasure Technologies, Inc.
2016-09-15
Histofreezer - Histofreezer, Kit, U.S., 36F1C
Orasure Technologies, Inc.
2016-09-15
Histofreezer - Histofreezer Kit, U.S., 40T1C
Orasure Technologies, Inc.
2016-09-15
OraSure Quick Flu 22-Count Flu A + B Kit - 1001-0320
Orasure Technologies, Inc.
2016-11-10
OraSure Quickflu Nasopharyngeal Wash / Aspirate - 1001-0321
Orasure Technologies, Inc.
2016-11-25
OraSure QuickFlu Positive and Negative Control Kit - 1001-0323
Orasure Technologies, Inc.
2018-03-23
Histofreezer - Histofreezer, US Sample, 5M1C
Orasure Technologies, Inc.
2016-09-16
OraQuick HIV Self-Test - 3001-3822U2
Orasure Technologies, Inc.
2026-05-08
OraQuick HIV Self-Test - 3001-3822UR2
Orasure Technologies, Inc.
2026-05-08
Intercept - Intercept Collection Device
Orasure Technologies, Inc.
2016-07-29
Q.E.D. Saliva Alcohol Test A150 - 60156
Orasure Technologies, Inc.
2016-07-29
Kit, MP Cotinine Serum 100 plate - 1124EC
Orasure Technologies, Inc.
2021-01-22
Methamphetamine Intercept 2 Plate Kit - 1104IT
Orasure Technologies, Inc.
2016-09-12
Auto-Lyte - Auto-Lyte Cotinine Urine 1000mL
Orasure Technologies, Inc.
2016-04-29
Amphetamine Intercept 5 Plate Kit - 1103IB
Orasure Technologies, Inc.
2016-09-12
Amphetamine Intercept 100 Plate Kit - 1103IC
Orasure Technologies, Inc.
2016-09-12
Methamphetamine Intercept 5 Plate Kit - 1104IB
Orasure Technologies, Inc.
2016-09-12
Methamphetamine Intercept 100 Plate Kit - 1104IC
Orasure Technologies, Inc.
2016-09-12
Barbiturates Intercept 5 Plate Kit - 1108IB
Orasure Technologies, Inc.
2016-09-12
Barbiturates Intercept 100 Plate Kit - 1108IC
Orasure Technologies, Inc.
2016-09-12
Barbiturates Intercept 2 Plate Kit - 1108IT
Orasure Technologies, Inc.
2016-09-12
Benzodiazepine Intercept 5 Plate Kit - 1110IB
Orasure Technologies, Inc.
2016-09-12
Benzodiazepine Intercept 100 Plate Kit - 1110IC
Orasure Technologies, Inc.
2016-09-12
Benzodiazepine Intercept 2 Plate Kit - 1110IT
Orasure Technologies, Inc.
2016-09-12
Cannabinoids Intercept 5 Plate Kit - 1118IB
Orasure Technologies, Inc.
2016-09-12
Cannabinoids Intercept 100 Plate Kit - 1118IC
Orasure Technologies, Inc.
2016-09-12
Cannabinoids Intercept 2 Plate Kit - 1118IT
Orasure Technologies, Inc.
2016-09-12
Cocaine Intercept 5 Plate Kit - 1122IB
Orasure Technologies, Inc.
2016-09-12
Cocaine Intercept 100 Plate Kit - 1122IC
Orasure Technologies, Inc.
2016-09-12
Cocaine Intercept 2 Plate Kit - 1122IT
Orasure Technologies, Inc.
2016-09-12
Methadone Intercept 5 Plate Kit - 1142IB
Orasure Technologies, Inc.
2016-09-12
Methadone Intercept 100 Plate Kit - 1142IC
Orasure Technologies, Inc.
2016-09-12
Methadone Intercept 2 Plate Kit - 1142IT
Orasure Technologies, Inc.
2016-09-12
Cotinine Serum 5 Plate Kit - 1124EB
Orasure Technologies, Inc.
2016-09-16
Cotinine Serum 2 Plate Kit - 1124ET
Orasure Technologies, Inc.
2016-09-16
Cocaine OraSure 5 Plate Kit - 1122SB
Orasure Technologies, Inc.
2016-09-12
Cocaine OraSure 100 Plate Kit - 1122SC
Orasure Technologies, Inc.
2016-09-12
Auto-Lyte - Auto-Lyte Cotinine Urine 100mL
Orasure Technologies, Inc.
2016-04-29

78 records. Showing 1-40. Next