Device Classification Name |
variola virus nucleic acid-based detection assay
|
De Novo Number |
DEN160016 |
Device Name |
Variola virus Real-Time PCR Assay |
Requester |
centers for disease control and prevention (cdc) |
1600 clifton road ne, ms-c18 |
atlanta,
GA
30329
|
|
Contact |
yon yu |
|
Regulation Number | 866.3316
|
Classification Product Code |
|
Date Received | 04/14/2016 |
Decision Date | 02/06/2017 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Microbiology
|
Review Advisory Committee |
Microbiology
|
Type |
Direct
|
|
|