Device Classification Name |
orthopedic infection microbial multiplex nucleic acid detection system
|
De Novo Number |
DEN200066 |
Device Name |
BioFire Joint Infection (JI) Panel |
Requester |
biofire diagnostics, llc |
515 colorow drive |
salt lake city,
UT
84108
|
|
Contact |
kevin bourzac |
|
Regulation Number | 866.3988
|
Classification Product Code |
|
Date Received | 10/27/2020 |
Decision Date | 04/29/2022 |
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
|
|
|