Gabapentin Assay

OTF · Class II — Moderate Risk (510(k) clearance required) · Clinical Toxicology · 21 CFR 862.3350

Classification

FDA Product Code: OTF
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 862.3350
Review panel: TX
Medical specialty: Clinical Toxicology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown