FDA.reportPublic FDA data

De Novo DEN170030

Device
VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody
Contact
carol "penny" houston
De Novo number
DEN170030
Product code
PZJ
Regulation
864.1866
Classification name
lynch syndrome test system
Decision
granted (DENG)
Decision date
2017-10-27
Date received
2017-05-30
Classification advisory
Immunology
Review advisory
Pathology
Type
Direct

Current FDA Classification#

Product code
PZJ
Device name
Lynch Syndrome Test System
Medical specialty
Immunology
Device class
2
Regulation
864.1866
Implant
N
Life sustain/support
N