FDA.reportPublic FDA data

Product code GIT

Device name
Reagent & Control, Partial Thromboplastin Time
Medical specialty
Hematology
Device class
2
Regulation number
864.7925
Review panel
HE
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
Y
Summary malfunction reporting
Eligible
Source
FDA openFDA device classification dataset