Device Classification Name |
hiv-1 genotyping assay using ngs technology
|
De Novo Number |
BR190330 |
Device Name |
Sentosa SQ HIV Genotyping Assay |
Product Code | QIC
|
Device Class | II |
Regulation Number | 866.3955 |
Submission Type |
Direct De Novo |
Requestor |
Vela Diagnostics USA Inc |
353 c us route 46 west |
suite 250 |
fairfield,
NJ
07004
|
|
Date Received | 03/19/2019 |
Decision Date | 11/05/2019 |
Decision | Granted - Direct De Novo |
Expedited Review |
No
|
Third Party Review |
Not Third Party Elligble
|
In Vitro Device? |
Yes
|
|
|