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Lamotrigine Assay

FDA product code ORH · 2 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
2007-01-12 – 2010-10-29

for the quantitative determination of lamotrigine in human serum or plasma on automated clinical chemistry analyzers.

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