ORI

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Levetiracetam Assay

Device class

Class II (moderate risk)

Regulation

21 CFR 862.3350

Medical specialty

Clinical Toxicology

Flags

Third-party review eligible

FDA definition

For the quantitative determination of levetiracetam in human serum or plasma.

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