|
Device
|
Applicant
|
PMA Number
|
Decision Date
|
cobas HCV
|
Roche Molecular Systems, Inc. |
P150015 S042 |
12/10/2020 |
Abbott RealTime HCV Assay
|
ABBOTT MOLECULAR, INC. |
P100017 S023 |
12/08/2020 |
cobas HCV
|
Roche Molecular Systems, Inc. |
P150015 S039 |
11/02/2020 |
cobas HCV
|
Roche Molecular Systems, Inc. |
P150015 S041 |
10/07/2020 |
COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0
|
Roche Molecular Systems, Inc. |
P060030 S084 |
08/26/2020 |
cobas HCV
|
Roche Molecular Systems, Inc. |
P150015 S040 |
08/26/2020 |
Aptima HCV RNA Qualitative Assay
|
GEN-PROBE |
P020011 S016 |
07/21/2020 |
Aptima HCV Quant Dx Assay
|
HOLOGIC, INC. |
P160023 S019 |
07/21/2020 |
Alinity m HCV
|
Abbott Molecular, Inc. |
P190025 S002 |
06/09/2020 |
COBAS® TaqMan® HCV Test, v2.0, for Use with the Hi...
|
Roche Molecular Systems, Inc. |
P060030 S083 |
05/14/2020 |