Device Classification Name |
nucleic acid amplification test for the quantitation of epstein-barr virus (ebv) dna
|
De Novo Number |
DEN200015 |
Device Name |
cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit |
Requester |
roche molecular systems, inc. |
4300 hacienda drive |
pleasanton,
CA
94588 -2722
|
|
Contact |
rita hoady |
|
Regulation Number | 866.3183
|
Classification Product Code |
|
Date Received | 03/02/2020 |
Decision Date | 07/30/2020 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Microbiology
|
Review Advisory Committee |
Microbiology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
Predetermined Change Control Plan Authorized |
No
|
|
|