Product code MZO
- Device name
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3169
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P050042S047 | ARCHITECT Anti-HCV / Alinity i Anti-HCV | Abbott Laboratories, Inc. | 2021-12-15 |
| P050042S046 | ARCHITECT Anti-HCV (LN 1L79) | Abbott Laboratories, Inc. | 2021-12-06 |
| P190011S004 | LIAISON XL MUREX HCV Ab, LIAISON XL MUREX Control HCV Ab | DiaSorin, Inc. | 2021-08-10 |
| P030056S020 | Atellica IM Hepatitis C (aHCV) Assay | Siemens Healthcare Diagnostics | 2021-04-27 |
| P050042S045 | ARCHITECT Anti-HCV Reagent Kit, Alinity i Anti-HCV Reagent Kit | Abbott Laboratories, Inc. | 2021-04-22 |
| P080027S039 | OraQuick HCV Rapid Antibody Test | OraSure Technologies, Inc. | 2021-04-20 |
| P030056S019 | ADVIA Centaur HCV ReadyPack Reagents, Atellica IM Hepatitis C (aHCV), Atellica IM Hepatitis C Quality Control(aHCV QC) | Siemens Healthcare Diagnostics | 2021-03-11 |
| P080027S038 | OraQuick HCV Rapid Antibody Test | OraSure Technologies, Inc. | 2021-02-25 |
| P080027S037 | OraQuick HCV Rapid Antibody Test | OraSure Technologies, Inc. | 2020-10-16 |
| P050042S044 | ARCHITECT Anti-HCV, Alinity i Anti-HCV | Abbott Laboratories, Inc. | 2020-08-28 |
| P030056S018 | ADVIA CENTAUR HCV ReadyPack Reagents and Quality Control Materials | Siemens Healthcare Diagnostics | 2020-08-25 |
| P010021S033 | VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator | Ortho-Clinical Diagnostics, Inc. | 2020-08-07 |
| P190011S002 | LIAISON XL MUREX HCV Ab | DiaSorin, Inc. | 2020-08-06 |
| P030056S017 | ADVIA Centaur HCV, and Atellica HCV | Siemens Healthcare Diagnostics | 2020-06-21 |
| P050042S040 | Alinity i Anti-HCV Reagent Kit | Abbott Laboratories, Inc. | 2020-06-05 |
| P050042S042 | ARCHITECT Anti-HCV | Abbott Laboratories, Inc. | 2020-05-23 |
| P050042S041 | Alinity i Anti-HCV | Abbott Laboratories, Inc. | 2020-05-23 |
| P050042S043 | ARCHITECT Anti-HCV and Alinity i Anti-HCV | Abbott Laboratories, Inc. | 2020-04-29 |
| P190011S001 | LIAISON XL MUREX HCV Ab | DiaSorin, Inc. | 2020-04-08 |
| P030056S016 | Atellica IM Hepatitis C (aHCV) Assay | Siemens Healthcare Diagnostics | 2020-04-03 |
| P030056S015 | ADVIA Centaur and Atellica IM HCV | Siemens Healthcare Diagnostics | 2020-03-19 |
| P190011 | LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV Ab | DiaSorin, Inc. | 2019-10-18 |
| P080027S035 | OraQuick HCV Rapid Antibody Test | OraSure Technologies, Inc. | 2019-09-11 |
| P050042S039 | Architect Anti-HCV and Alinity i Anti-HCV | Abbott Laboratories, Inc. | 2019-08-13 |
| P010021S032 | VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator | Ortho-Clinical Diagnostics, Inc. | 2019-06-19 |
| P050042S034 | Alinity i Anti-HCV Reagent Kit, Alinity i Anti-HCV Calibrator, Alinity i Anti-HCV Controls | Abbott Laboratories, Inc. | 2019-06-18 |
| P140021S016 | Elecsys Anti-HCV II | Roche Diagnostics Operations, Inc. | 2019-04-24 |
| P090009S018 | Elecsys Anti-HCV Immunoassay | Roche Diagnostics Corp. | 2019-04-24 |
| P090008S021 | Elecsys Anti-HCV Immunoassay | Roche Diagnostics Corp. | 2019-04-24 |
| P090007S020 | Elecsys Anti-HCV Immunoassay | Roche Diagnostics Corp. | 2019-04-24 |
Related 510(k) Records#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613336217092 | Elecsys Anti-HCV II | Roche Diagnostics GmbH | 2025-10-27 |
| 07613336166956 | Elecsys Anti-HCV II | Roche Diagnostics GmbH | 2023-01-23 |
| 07613336166970 | Elecsys Anti-HCV II | Roche Diagnostics GmbH | 2023-01-23 |
| 07613336166994 | Elecsys Anti-HCV II | Roche Diagnostics GmbH | 2023-01-23 |
| 00630414301341 | Atellica IM aHCV 200T | Siemens Healthcare Diagnostics Inc. | 2021-01-15 |
| 00380740130657 | Alinity | Abbott GmbH | 2019-10-11 |
| 00380740130633 | Alinity | Abbott GmbH | 2019-10-11 |
| 00380740130640 | Alinity | Abbott GmbH | 2019-10-11 |
| 00630414278742 | Atellica IM aHCV 200T | Siemens Healthcare Diagnostics Inc. | 2018-11-01 |
| 00630414278759 | ADVIA Centaur HCV | Siemens Healthcare Diagnostics Inc. | 2018-11-01 |
| 00630414597867 | Atellica™ IM aHCV | Siemens Healthcare Diagnostics Inc. | 2018-10-16 |
| 00630414597874 | Atellica™ IM aHCV QC | Siemens Healthcare Diagnostics Inc. | 2018-10-16 |
| 04015630939947 | Elecsys Anti-HCV II | Roche Diagnostics GmbH | 2017-12-18 |
| 07613336154311 | Elecsys Anti-HCV II | Roche Diagnostics GmbH | 2017-10-03 |
| 07613336154304 | Elecsys Anti-HCV II | Roche Diagnostics GmbH | 2017-10-03 |
| 07613336154328 | PreciControl Anti-HCV | Roche Diagnostics GmbH | 2017-10-03 |
| 04015630936663 | Elecsys AntiHCV II immunoassay | Roche Diagnostics GmbH | 2015-09-21 |
| 04015630936670 | Elecsys AntiHCV II immunoassay | Roche Diagnostics GmbH | 2015-09-21 |
| M769HCV271 | Hepatitis C Check | Home Access Health Corporation | 2015-09-03 |
| 04015630919277 | Elecsys PreciControl Anti-HCV | Roche Diagnostics GmbH | 2014-12-18 |
| 00380740001391 | ARCHITECT | Abbott GmbH | 2014-11-18 |
| 10758750001095 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2014-10-24 |
| 10758750002801 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2014-10-22 |
| 10758750001101 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2014-10-22 |
| 00630414473161 | ADVIA Centaur® HCV | Siemens Healthcare Diagnostics Inc. | 2014-09-24 |
| 00630414473178 | ADVIA Centaur® Systems HCV QC | Siemens Healthcare Diagnostics Inc. | 2014-09-24 |
| 04015630919260 | Elecsys Anti-HCV Immunoassay | Roche Diagnostics GmbH | 2014-09-11 |
| 20608337000539 | OraQuick HCV Rapid Antibody Test | Orasure Technologies, Inc. | 2014-09-05 |
| 00608337000542 | OraQuick HCV Rapid Antibody Test Kit Controls | Orasure Technologies, Inc. | 2014-09-05 |
| 00608337000535 | OraQuick HCV Rapid Antibody Test | Orasure Technologies, Inc. | 2014-09-05 |