OraQuick HCV Rapid Antibody Test
ORASURE TECHNOLOGIES INC.
| 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 |
| 3004142665 | 3004142665 | ORASURE TECHNOLOGIES INC. | 1 | N | 2026-01-01 | 220 EAST FIRST STREET 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 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 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 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 11685 | 1451668060 | P080027 | ORAQUICK HCV RAPID ANTIBODY TEST | MZO | 2010-06-25 |
| 42145 | 1451668060 | P080027 | ORAQUICK HCV RAPID ANTIBODY TEST | MZO | 2010-06-25 |
| 115187 | 1451668060 | P080027 | ORAQUICK HCV RAPID ANTIBODY TEST | MZO | 2010-06-25 |
| 218464 | 1451668060 | P080027 | ORAQUICK HCV RAPID ANTIBODY TEST | MZO | 2010-06-25 |
| 305166 | 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 |
| 42145 | 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 |
| 218464 | 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 |
| 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 |
| 11685 | 1123585146 | K982831 | AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U | JXM | 1998-11-12 |
| 218464 | 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 |
| 218464 | 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 |
| 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 |
| 11685 | 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 |
| 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 |
| 11685 | 2042852518 | K981341 | STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION) | DJG | 1998-05-22 |
| 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 |
| 11685 | 1624928550 | K974234 | MICRO-PLATE COTININE EIA | MKU | 1998-05-14 |
| 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 |
| 11685 | 1523463735 | K970357 | EPISCREEN | PJD | 1997-03-10 |
| 42145 | 1523463735 | K970357 | EPISCREEN | PJD | 1997-03-10 |
| 115187 | 1523463735 | K970357 | EPISCREEN | PJD | 1997-03-10 |
| 218464 | 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 |
| 11685 | 1650792783 | K083746 | BIOSIGN FLU A+B | PSZ | 2010-11-10 |
| 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 |
| 11685 | 1414411589 | K023487 | HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME | GEH | 2003-03-20 |
| 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 |
| 11685 | 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 |
| 115187 | 1531335080 | K013882 | OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I | JXM | 2002-04-17 |
| 218464 | 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 |
| 42145 | 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 |
| 218464 | 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 |
| 11685 | 1887009359 | K002010 | STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421 | DJR | 2000-11-29 |
| 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 |
| 42145 | 2017106567 | K001197 | COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA | DIO | 2000-05-11 |
| 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 | 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 |
| 11685 | 1956111218 | DEN190025 | OraQuick Ebola Rapid Antigen Test | QID | 2019-10-10 |
| 42145 | 1956111218 | DEN190025 | OraQuick Ebola Rapid Antigen Test | QID | 2019-10-10 |
| 115187 | 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 |
| 11685 | 1717835327 | BP950004 | |||
| 115187 | 1717835327 | BP950004 | |||
| 218464 | 1717835327 | BP950004 | |||
| 11685 | 2016193288 | BP910001 | |||
| 115187 | 2016193288 | BP910001 | |||
| 218464 | 2016193288 | BP910001 | |||
| 305166 | 2016193288 | BP910001 | |||
| 11685 | 1708853313 | BP120001 | |||
| 42145 | 1708853313 | BP120001 | |||
| 115187 | 1708853313 | BP120001 | |||
| 218464 | 1708853313 | BP120001 | |||
| 305166 | 1708853313 | BP120001 | |||
| 11685 | 1046624333 | BP010047 | |||
| 42145 | 1046624333 | BP010047 | |||
| 115187 | 1046624333 | BP010047 | |||
| 218464 | 1046624333 | BP010047 | |||
| 305166 | 1046624333 | BP010047 | |||
| 11685 | 1229218134 | ||||
| 42145 | 1229218134 | ||||
| 115187 | 1229218134 | ||||
| 218464 | 1229218134 | ||||
| 11685 | 1536384484 | ||||
| 115187 | 1536384484 | ||||
| 305166 | 1536384484 | ||||
| 11685 | 1607344736 | ||||
| 305166 | 1607344736 | ||||
| 305166 | 1612108058 | ||||
| 11685 | 1680089497 | ||||
| 305166 | 1938189830 | ||||
| 305166 | 2005555730 | ||||
| 11685 | 2031241003 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| DIO | 11 | 2000-05-11 |
| PJD | 8 | 2001-06-06 |
| MKU | 8 | 1998-05-18 |
| DJG | 7 | 1998-05-22 |
| JXM | 6 | 2002-04-17 |
| QID | 5 | 2019-10-10 |
| MZO | 5 | 2010-06-25 |
| LCM | 5 | 2000-05-15 |
| OYJ | 4 | 2020-01-14 |
| PSZ | 4 | 2010-11-10 |
| GEH | 4 | 2003-03-20 |
| DJR | 4 | 2000-11-29 |
| DKZ | 4 | 2000-04-03 |
| LAF | 4 | 2000-04-03 |
| LDJ | 3 | 2001-01-26 |
| DIS | 3 | 2000-12-06 |
| DIC | 3 | 1990-04-05 |
| QPO | 1 | 2021-11-03 |
ORASURE TECHNOLOGIES INC.
ORASURE TECHNOLOGIES INC.
ORASURE TECHNOLOGIES INC.
ORASURE TECHNOLOGIES INC.
ORASURE TECHNOLOGIES INC.
ORASURE TECHNOLOGIES INC.
ORASURE TECHNOLOGIES INC.
ORASURE TECHNOLOGIES INC.
ORASURE TECHNOLOGIES INC.
ORASURE TECHNOLOGIES INC.
ORASURE TECHNOLOGIES INC.
ORASURE TECHNOLOGIES INC.
ORASURE TECHNOLOGIES INC.
ORASURE TECHNOLOGIES INC.
ORASURE TECHNOLOGIES INC.
ORASURE TECHNOLOGIES INC.
ORASURE TECHNOLOGIES INC.
ORASURE TECHNOLOGIES INC.
ORASURE TECHNOLOGIES INC.
ORASURE TECHNOLOGIES INC.
ORASURE TECHNOLOGIES INC.
ORASURE TECHNOLOGIES INC.
ORASURE TECHNOLOGIES INC.
ORASURE TECHNOLOGIES INC.
ORASURE TECHNOLOGIES INC.
ORASURE TECHNOLOGIES INC.
ORASURE TECHNOLOGIES INC.
ORASURE TECHNOLOGIES INC.
ORASURE TECHNOLOGIES INC.
ORASURE TECHNOLOGIES INC.
ORASURE TECHNOLOGIES INC.
ORASURE TECHNOLOGIES INC.
ORASURE TECHNOLOGIES INC.
ORASURE TECHNOLOGIES INC.
ORASURE TECHNOLOGIES INC.
ORASURE TECHNOLOGIES INC.
ORASURE TECHNOLOGIES, INC.
ORASURE TECHNOLOGIES, INC.
ORASURE TECHNOLOGIES, INC.
ORASURE TECHNOLOGIES, INC.
ORASURE TECHNOLOGIES, INC.
ORASURE TECHNOLOGIES, INC.
ORASURE TECHNOLOGIES, INC.
ORASURE TECHNOLOGIES, INC.
ORASURE TECHNOLOGIES, INC.
ORASURE TECHNOLOGIES, INC.
ORASURE TECHNOLOGIES, INC.
ORASURE TECHNOLOGIES, INC.
ORASURE TECHNOLOGIES, INC.
ORASURE TECHNOLOGIES, INC.
ORASURE TECHNOLOGIES, INC.
ORASURE TECHNOLOGIES, INC.
ORASURE TECHNOLOGIES, INC.
ORASURE TECHNOLOGIES, INC.
ORASURE TECHNOLOGIES, INC.
ORASURE TECHNOLOGIES, INC.
ORASURE TECHNOLOGIES, INC.
ORASURE TECHNOLOGIES, INC.
ORASURE TECHNOLOGIES, INC.
ORASURE TECHNOLOGIES, INC.
ORASURE TECHNOLOGIES, INC.
ORASURE TECHNOLOGIES, INC.
ORASURE TECHNOLOGIES, INC.
ORASURE TECHNOLOGIES, INC.
ORASURE TECHNOLOGIES, INC.
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