Device Classification Name |
multi-analyte respiratory virus antigen detection test
|
De Novo Number |
DEN240029 |
Device Name |
Healgen Rapid Check COVID-19/Flu A&B Antigen Test |
Requester |
healgen |
3818 fuqua street |
houston,
TX
77047
|
|
Contact |
bingliang fang |
|
Regulation Number | 866.3987
|
Classification Product Code |
|
Date Received | 06/07/2024 |
Decision Date | 10/07/2024 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Microbiology
|
Review Advisory Committee |
Microbiology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|