|
Device
|
Applicant
|
PMA Number
|
Decision Date
|
COBAS® AmpliPrep/COBAS® TaqMan® HBV Test
|
Roche Molecular Systems, Inc. |
P050028 S088 |
08/23/2023 |
COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test, v2.0
|
Roche Molecular Systems, Inc. |
P050028 S086 |
11/14/2022 |
COBAS® AmpliPrep, COBAS® TaqMan® HBV Test, v2.0
|
Roche Molecular Systems, Inc. |
P050028 S087 |
08/17/2023 |
COBAS TaqMan HBV Test, High Pure System Viral Nucl...
|
Roche Molecular Systems, Inc. |
P050028 S066 |
07/03/2018 |
COBAS TaqMan HBV Test, High Pure System Viral Nucl...
|
Roche Molecular Systems, Inc. |
P050028 S054 |
10/18/2016 |
COBAS TAQMAN HBV TEST, HIGH PURE SYSTEM VIRAL NUCL...
|
Roche Molecular Systems, Inc. |
P050028 S047 |
07/23/2015 |
COBAS TaqMan HBV Test, For Use With High Pure Syst...
|
Roche Molecular Systems, Inc. |
P050028 S055 |
05/10/2017 |
Cobas TaqMan HBV Test, Cobas AmpliPep/Cobas, TaqMa...
|
Roche Molecular Systems, Inc. |
P050028 S061 |
03/26/2018 |
Cobas TaqMan HBV Test v2.0
|
Roche Molecular Systems, Inc. |
P050028 S060 |
12/20/2017 |
COBAS TaqMan HBV Test for Use with the High Pure S...
|
Roche Molecular Systems, Inc. |
P050028 S056 |
08/09/2017 |