Product code OBF
- Device name
- Assay, Genotyping, Hepatitis C Virus
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3170
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- In vitro diagnostic device for qualitative detection and classification of 8 clinically relevant Hepatitis C Virus RNA genotypes
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P120012S019 | Abbott RealTime HCV Genotype II | Abbott Molecular | 2021-03-05 |
| P160016S005 | VERSANT HCV Genotype 2.0 Assay (LiPA) | Fujirebio Europe N.V. | 2020-09-23 |
| P160016S006 | VERSANT HCV Genotype 2.0 Assay (LiPA) | Fujirebio Europe N.V. | 2020-08-27 |
| P160016S004 | Versant HCV Genotype 2.0 Assay (LiPA) | Fujirebio Europe N.V. | 2019-09-20 |
| P120012S018 | Abbott RealTime HCV GT II | Abbott Molecular | 2019-05-15 |
| P160016S003 | VERSANT HCV Genotype 2.0 Assay (LiPA) | Fujirebio Europe N.V. | 2019-04-05 |
| P120012S017 | Abbott RealTime HCV Genotype II Assay | Abbott Molecular | 2018-06-21 |
| P160016S001 | VERSANT HCV Genotype 2.0 Assay (LiPA) | Fujirebio Europe N.V. | 2018-02-08 |
| P120012S016 | Abbott Real Time HCV Genotype II Amplification Reagent Kit / HCV Genotype II Control Kit | Abbott Molecular | 2017-09-01 |
| P160016 | VERSANT HCV GENOTYPE 2.0 ASSAY (LiPA) | Fujirebio Europe N.V. | 2017-03-14 |
| P120012S015 | ABBOTT REALTIME HCV GENOTYPE II | Abbott Molecular | 2016-12-23 |
| P120012S014 | ABBOTT REALTIME HCV GENOTYPE II ASSAY | Abbott Molecular | 2016-06-30 |
| P120012S013 | ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, ABBOTT MSAMPLE PREPARATION SYSTEM | Abbott Molecular | 2016-06-10 |
| P120012S011 | ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG) | Abbott Molecular | 2016-04-20 |
| P120012S012 | ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG) | Abbott Molecular | 2016-04-12 |
| P120012S010 | ABBOTT REALTIME HCV GENOTYPE II | Abbott Molecular | 2016-03-07 |
| P120012S009 | ABBOTT REALTIME HCV GENOTYPE II | Abbott Molecular | 2015-10-09 |
| P120012S007 | REALTIME HCV GENOTYPE II | Abbott Molecular | 2015-04-23 |
| P120012S006 | REALTIME HCV GENOTYPE II | Abbott Molecular | 2014-12-10 |
| P120012S005 | ABBOTT REAL TIME HCV GENOTYPE II, GENOTYPE II CONTROL KIT, ABBOTT MSAMPLE PREPARATION SYSTEM | Abbott Molecular | 2014-11-20 |
| P120012S004 | ABBOTT REAL TIME HCV GENOTYPE II | Abbott Molecular | 2014-09-25 |
| P120012S003 | ABBOTT REALTIME HCV GENOTYPE II | Abbott Molecular | 2013-08-20 |
| P120012S002 | ABBOTT REALTIME HCV GENOTYPE II | Abbott Molecular | 2013-08-13 |
| P120012S001 | ABBOTT REAL TIME HCV GENOTYPE 11 | Abbott Molecular | 2013-08-01 |
| P120012 | ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG) | Abbott Molecular | 2013-06-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05414470156870 | LiRAS for LiPA HCV v1 | Fujirebio Europe | 2025-05-30 |
| 05414470816590 | INNO-LiPA HCV 2.0 Genotyping | Fujirebio Europe | 2025-05-30 |
| 05414470816606 | INNO-LiPA HCV 2.0 Amp | Fujirebio Europe | 2025-05-30 |
| 05414470816613 | INNO-LiPA HCV 2.0 Control | Fujirebio Europe | 2025-05-30 |
| 05414470816620 | INNO-LiPA HCV 2.0 Genotyping | Fujirebio Europe | 2025-05-30 |
| 05414470816637 | INNO-LiPA HCV 2.0 Amp | Fujirebio Europe | 2025-05-30 |
| 00884999037472 | RealTime | ABBOTT MOLECULAR INC. | 2017-12-15 |
| 00630414602882 | VERSANT HCV 2.0 LiPA | Siemens Healthcare Diagnostics Inc. | 2017-09-15 |
| 00630414602875 | VERSANT HCV 2.0 LiPA | Siemens Healthcare Diagnostics Inc. | 2017-09-15 |
| 00630414000534 | VERSANT | Siemens Healthcare Diagnostics Inc. | 2017-09-15 |
| 00630414000510 | VERSANT HCV Control 2.0 Kit (LiPA) | Siemens Healthcare Diagnostics Inc. | 2017-09-15 |
| 00630414000503 | VERSANT HCV 2.0 LiPA | Siemens Healthcare Diagnostics Inc. | 2017-09-15 |
| 00630414000497 | VERSANT HCV 2.0 LiPA | Siemens Healthcare Diagnostics Inc. | 2017-09-15 |
| 00884999042513 | RealTime | ABBOTT MOLECULAR INC. | 2016-09-01 |
| 00884999036444 | RealTime | ABBOTT MOLECULAR INC. | 2014-11-20 |
| 00884999036147 | RealTime | ABBOTT MOLECULAR INC. | 2014-11-20 |
| 00884999036130 | RealTime | ABBOTT MOLECULAR INC. | 2014-11-20 |
| 00884999034266 | RealTime | ABBOTT MOLECULAR INC. | 2014-11-20 |