Product code OTF

Device name

Gabapentin Assay

Medical specialty

Clinical Toxicology

Device class

2

Regulation number

862.3350

Review panel

TX

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

Definition

Test for the quantitative determination of gabapentin in human serum or plasma. Gabapentin concentrations can be used as an aid in management of patients treated with gabapentin.

Source

FDA openFDA device classification dataset