Lamotrigine Assay
The Lamotrigine Assay (product code ORH) is an in vitro diagnostic test for the quantitative determination of lamotrigine concentrations in human serum or plasma, intended for use on automated clinical chemistry analyzers. Lamotrigine is an antiepileptic drug, and therapeutic drug monitoring via this assay aids in managing patients on lamotrigine therapy. As an FDA Class 2 device under regulation 862.3350, it requires 510(k) premarket clearance and falls within the Clinical Toxicology specialty. The device is eligible for third-party review and is neither an implant nor life-sustaining.
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Basic Information
- Product Code
- ORH
- Device Class
- FDA class 2
- Regulation Number
- 862.3350
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
Definition
for the quantitative determination of lamotrigine in human serum or plasma on automated clinical chemistry analyzers.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.