Product code MZP
- Device name
- Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,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
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P060030S086 | COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0 | Roche Molecular Systems, Inc. | 2021-08-11 |
| P150015S043 | cobas HCV | Roche Molecular Systems, Inc. | 2021-06-02 |
| P190025S006 | Alinity m HCV | Abbott Molecular, Inc. | 2021-06-01 |
| P190025S004 | Alinity m HCV | Abbott Molecular, Inc. | 2021-04-26 |
| P060030S085 | COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0 | Roche Molecular Systems, Inc. | 2021-03-09 |
| P190025S005 | Alinity m HCV | Abbott Molecular, Inc. | 2021-03-05 |
| P100017S024 | Abbott RealTime HCV | Abbott Molecular, Inc. | 2021-03-05 |
| P190025S003 | Alinity m HCV | Abbott Molecular, Inc. | 2021-01-19 |
| P150015S042 | cobas HCV | Roche Molecular Systems, Inc. | 2020-12-10 |
| P100017S023 | Abbott RealTime HCV Assay | Abbott Molecular, Inc. | 2020-12-08 |
| P150015S039 | cobas HCV | Roche Molecular Systems, Inc. | 2020-11-02 |
| P150015S041 | cobas HCV | Roche Molecular Systems, Inc. | 2020-10-07 |
| P150015S040 | cobas HCV | Roche Molecular Systems, Inc. | 2020-08-26 |
| P060030S084 | COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 | Roche Molecular Systems, Inc. | 2020-08-26 |
| P160023S019 | Aptima HCV Quant Dx Assay | Hologic, Inc. | 2020-07-21 |
| P020011S016 | Aptima HCV RNA Qualitative Assay | Gen-Probe | 2020-07-21 |
| P190025S002 | Alinity m HCV | Abbott Molecular, Inc. | 2020-06-09 |
| P150015S038 | cobas HCV | Roche Molecular Systems, Inc. | 2020-05-14 |
| P060030S083 | COBAS® TaqMan® HCV Test, v2.0, for Use with the High Pure System and COBAS® AmpliPrep/ COBAS® TaqMan® HCV Test, v2.0 | Roche Molecular Systems, Inc. | 2020-05-14 |
| P190025S001 | Alinity m HCV | Abbott Molecular, Inc. | 2020-05-06 |
| P190025 | Alinity m HCV | Abbott Molecular, Inc. | 2020-03-23 |
| P060030S082 | Cobas AmpliPrep/Cobas Taqman HCV Test v2.0 | Roche Molecular Systems, Inc. | 2020-02-20 |
| P160023S017 | Aptima HCV Quant Dx Assay | Hologic, Inc. | 2020-02-14 |
| P020011S015 | Aptima HCV RNA Qualitative Assay | Gen-Probe | 2020-02-14 |
| P150015S037 | cobas HCV | Roche Molecular Systems, Inc. | 2020-02-06 |
| P160023S016 | Aptima HCV Quant Dx Assay | Hologic, Inc. | 2020-01-21 |
| P150015S036 | COBAS HCV TEST | Roche Molecular Systems, Inc. | 2019-12-18 |
| P160023S015 | Aptima HCV Quant Dx Assay | Hologic, Inc. | 2019-12-16 |
| P150015S032 | Cobas HCV | Roche Molecular Systems, Inc. | 2019-12-11 |
| P060030S081 | COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0 | Roche Molecular Systems, Inc. | 2019-11-05 |
Related 510(k) Records#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00884999050860 | Alinity m | ABBOTT MOLECULAR INC. | 2023-08-18 |
| 00875197006391 | cobas® HCV | Roche Molecular Systems, Inc. | 2021-12-10 |
| 00884999048652 | Alinity m | ABBOTT MOLECULAR INC. | 2020-05-04 |
| 00884999047761 | Alinity m | ABBOTT MOLECULAR INC. | 2020-05-04 |
| 00884999047822 | Alinity m | ABBOTT MOLECULAR INC. | 2020-05-04 |
| 00884999047839 | Alinity m | ABBOTT MOLECULAR INC. | 2020-05-04 |
| 00884999037472 | RealTime | ABBOTT MOLECULAR INC. | 2017-12-15 |
| 04015630935390 | cobas 8800 System | Roche Diagnostics GmbH | 2017-04-20 |
| 04015630935406 | cobas 6800 System | Roche Diagnostics GmbH | 2017-04-20 |
| 15420045506787 | Aptima® | Hologic, Inc. | 2017-03-08 |
| 15420045506794 | Aptima® | Hologic, Inc. | 2017-03-08 |
| 15420045506800 | Aptima® | Hologic, Inc. | 2017-03-08 |
| 00875197004489 | cobas omni Specimen Diluent SPEC DIL) | Roche Diagnostics GmbH | 2015-12-04 |
| 00875197005127 | cobas® NHP Negative Control Kit | Roche Diagnostics GmbH | 2015-12-04 |
| 00875197004748 | cobas® HBV/HCV/HIV-1 Control Kit | Roche Diagnostics GmbH | 2015-12-04 |
| 00875197004694 | cobas® HCV Quantitative nucleic acid test for use on the cobas® 6800/8800 System | Roche Diagnostics GmbH | 2015-12-04 |
| 00875197004502 | cobas omni MGP Reagent MGP) | Roche Diagnostics GmbH | 2015-12-04 |
| 00875197004496 | cobas omni Lysis Reagent LYS) | Roche Diagnostics GmbH | 2015-12-04 |
| 00875197004472 | cobas omni Wash Reagent WASH) | Roche Diagnostics GmbH | 2015-12-04 |
| 00884999000698 | RealTime | ABBOTT MOLECULAR INC. | 2014-12-01 |
| 00884999000704 | RealTime | ABBOTT MOLECULAR INC. | 2014-11-20 |
| 00884999000711 | RealTime | ABBOTT MOLECULAR INC. | 2014-11-20 |
| 00884999000728 | RealTime | ABBOTT MOLECULAR INC. | 2014-11-20 |
| 00884999037434 | RealTime | ABBOTT MOLECULAR INC. | 2014-11-20 |
| 00875197004182 | COBAS® TaqMan® HCV Test For Use With the High Pure System | Roche Molecular Systems, Inc. | 2014-09-10 |
| 00875197003611 | COBAS® AmpliPrep / COBAS® TaqMan® HCV Test, v2.0 | Roche Molecular Systems, Inc. | 2014-09-09 |
| 00875197001983 | COBAS® AmpliPrep/ COBAS® TaqMan® HCV Test | Roche Molecular Systems, Inc. | 2014-09-09 |
| 15420045500235 | Aptima | Hologic, Inc. | 2014-08-06 |
| 15420045500228 | Aptima | Hologic, Inc. | 2014-08-06 |
| 15420045500211 | Aptima | Hologic, Inc. | 2014-08-06 |