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Gabapentin Assay

FDA product code OTF · 1 cleared devices

Class 2 Clinical Toxicology
Regulation
21 CFR 862.3350
Review panel
TX
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2010-11-23 – 2010-11-23

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.

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