ORASURE TECHNOLOGIES, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30032977633003297763ORASURE TECHNOLOGIES, INC.1N2026-01-01150 WEBSTER ST Bethlehem PA US 18015
30041426653004142665ORASURE TECHNOLOGIES INC.1N2026-01-01220 EAST FIRST STREET BETHLEHEM PA US 18015
30224748033022474803ORASURE TECHNOLOGIES, INC.1N2026-01-012685 Opus Way -- Bethlehem PA US 18020
25289092528909ORASURE TECHNOLOGIES, INC.1N2020-04-251745 EATON AVE. BETHLEHEM PA US 18018
30145121723014512172OraSure Technologies, Inc.1Y2020-04-252500 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 GUDIDProductPhoneEmail
00608337000047OraSure Quickflu Nasopharyngeal Wash / Aspirate - 1001-0321610-882-1820customercare@orasure.com
00608337000054OraSure QuickFlu Positive and Negative Control Kit - 1001-0323610-882-1820customercare@orasure.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
116851451668060P080027ORAQUICK HCV RAPID ANTIBODY TESTMZO2010-06-25
421451451668060P080027ORAQUICK HCV RAPID ANTIBODY TESTMZO2010-06-25
1151871451668060P080027ORAQUICK HCV RAPID ANTIBODY TESTMZO2010-06-25
2184641451668060P080027ORAQUICK HCV RAPID ANTIBODY TESTMZO2010-06-25
3051661451668060P080027ORAQUICK HCV RAPID ANTIBODY TESTMZO2010-06-25
116852018765012K993208STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104ILAF2000-04-03
421452018765012K993208STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104ILAF2000-04-03
1151872018765012K993208STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104ILAF2000-04-03
2184642018765012K993208STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104ILAF2000-04-03
116851120365358K992918STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103IDKZ2000-04-03
421451120365358K992918STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103IDKZ2000-04-03
1151871120365358K992918STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103IDKZ2000-04-03
2184641120365358K992918STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103IDKZ2000-04-03
116851123585146K982831AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210UJXM1998-11-12
2184641123585146K982831AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210UJXM1998-11-12
116851001430019K982801AUTO-LYTE PCP EIA, MODEL #1254ULCM1998-11-04
2184641001430019K982801AUTO-LYTE PCP EIA, MODEL #1254ULCM1998-11-04
116851643437115K982759AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222UDIO1998-11-20
421451643437115K982759AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222UDIO1998-11-20
1151871643437115K982759AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222UDIO1998-11-20
2184641643437115K982759AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222UDIO1998-11-20
116851841884229K982061STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)DIO1998-08-25
421451841884229K982061STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)DIO1998-08-25
1151871841884229K982061STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)DIO1998-08-25
2184641841884229K982061STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)DIO1998-08-25
116852042852518K981341STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION)DJG1998-05-22
421452042852518K981341STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION)DJG1998-05-22
1151872042852518K981341STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION)DJG1998-05-22
2184642042852518K981341STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION)DJG1998-05-22
421451808849595K974534MICRO-PLATE COTININE EIAMKU1998-05-18
1151871808849595K974534MICRO-PLATE COTININE EIAMKU1998-05-18
2184641808849595K974534MICRO-PLATE COTININE EIAMKU1998-05-18
116851624928550K974234MICRO-PLATE COTININE EIAMKU1998-05-14
1151871624928550K974234MICRO-PLATE COTININE EIAMKU1998-05-14
2184641624928550K974234MICRO-PLATE COTININE EIAMKU1998-05-14
1151871598418634K972481AUTO-LYTE COTININE EIAMKU1997-10-21
2184641598418634K972481AUTO-LYTE COTININE EIAMKU1997-10-21
116851523463735K970357EPISCREENPJD1997-03-10
421451523463735K970357EPISCREENPJD1997-03-10
1151871523463735K970357EPISCREENPJD1997-03-10
2184641523463735K970357EPISCREENPJD1997-03-10
421451550870916K924446MICRO-PLATE OPIATES ASSAYDJG1992-10-15
1151871550870916K924446MICRO-PLATE OPIATES ASSAYDJG1992-10-15
2184641550870916K924446MICRO-PLATE OPIATES ASSAYDJG1992-10-15
421451179553217K894001SALIVA ALCOHOL TESTDIC1990-04-05
1151871179553217K894001SALIVA ALCOHOL TESTDIC1990-04-05
2184641179553217K894001SALIVA ALCOHOL TESTDIC1990-04-05
3051661132411072K192920Oragene®•DxOYJ2020-01-14
3051661468694142K152556Oragene DxOYJ2016-05-26
3051661680089497K152464ORAcollect.DxOYJ2016-05-26
3051661607902791K110701ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500OYJ2011-12-02
116851650792783K083746BIOSIGN FLU A+BPSZ2010-11-10
421451650792783K083746BIOSIGN FLU A+BPSZ2010-11-10
1151871650792783K083746BIOSIGN FLU A+BPSZ2010-11-10
2184641650792783K083746BIOSIGN FLU A+BPSZ2010-11-10
116851414411589K023487HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAMEGEH2003-03-20
421451414411589K023487HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAMEGEH2003-03-20
1151871414411589K023487HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAMEGEH2003-03-20
2184641414411589K023487HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAMEGEH2003-03-20
116851531335080K013882OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110IJXM2002-04-17
421451531335080K013882OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110IJXM2002-04-17
1151871531335080K013882OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110IJXM2002-04-17
2184641531335080K013882OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110IJXM2002-04-17
116851897000117K011057INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXXPJD2001-06-06
421451897000117K011057INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXXPJD2001-06-06
1151871897000117K011057INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXXPJD2001-06-06
2184641897000117K011057INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXXPJD2001-06-06
421451538018577K002375STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118ILDJ2001-01-26
1151871538018577K002375STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118ILDJ2001-01-26
2184641538018577K002375STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118ILDJ2001-01-26
116851887009359K002010STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421DJR2000-11-29
421451887009359K002010STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421DJR2000-11-29
1151871887009359K002010STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421DJR2000-11-29
2184641887009359K002010STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421DJR2000-11-29
421451935965166K001976STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108IDIS2000-12-06
1151871935965166K001976STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108IDIS2000-12-06
2184641935965166K001976STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108IDIS2000-12-06
421452017106567K001197COCAINE METABOLITE INTERCEPT MICRO-PLATE EIADIO2000-05-11
1151872017106567K001197COCAINE METABOLITE INTERCEPT MICRO-PLATE EIADIO2000-05-11
2184642017106567K001197COCAINE METABOLITE INTERCEPT MICRO-PLATE EIADIO2000-05-11
421451341465966K000399STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541LCM2000-05-15
1151871341465966K000399STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541LCM2000-05-15
2184641341465966K000399STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541LCM2000-05-15
3051662031241003DEN200040OMNIgene GUT DxQPO2021-11-03
116851956111218DEN190025OraQuick Ebola Rapid Antigen TestQID2019-10-10
421451956111218DEN190025OraQuick Ebola Rapid Antigen TestQID2019-10-10
1151871956111218DEN190025OraQuick Ebola Rapid Antigen TestQID2019-10-10
2184641956111218DEN190025OraQuick Ebola Rapid Antigen TestQID2019-10-10
3051661956111218DEN190025OraQuick Ebola Rapid Antigen TestQID2019-10-10
116851717835327BP950004
1151871717835327BP950004
2184641717835327BP950004
116852016193288BP910001
1151872016193288BP910001
2184642016193288BP910001
3051662016193288BP910001
116851708853313BP120001
421451708853313BP120001
1151871708853313BP120001
2184641708853313BP120001
3051661708853313BP120001
116851046624333BP010047
421451046624333BP010047
1151871046624333BP010047
2184641046624333BP010047
3051661046624333BP010047
116851229218134
421451229218134
1151871229218134
2184641229218134
116851536384484
1151871536384484
3051661536384484
116851607344736
3051661607344736
3051661612108058
116851680089497
3051661938189830
3051662005555730
116852031241003

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DIO112000-05-11
PJD82001-06-06
MKU81998-05-18
DJG71998-05-22
JXM62002-04-17
QID52019-10-10
MZO52010-06-25
LCM52000-05-15
OYJ42020-01-14
PSZ42010-11-10
GEH42003-03-20
DJR42000-11-29
DKZ42000-04-03
LAF42000-04-03
LDJ32001-01-26
DIS32000-12-06
DIC31990-04-05
QPO12021-11-03

PMA#

PMN#

GUDID#

78 records. Showing 1-40. Next