Fluorescence Polarization Immunoassay, Carbamazepine

Device Code: 6226

Product Code(s): LGI

Device Classification Information

Device Type ID6226
Device NameFluorescence Polarization Immunoassay, Carbamazepine
Regulation DescriptionNeuroleptic Drugs Radioreceptor Assay Test System.
Regulation Medical SpecialtyToxicology
Review PanelToxicology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number862.3645 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeLGI
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID6226
DeviceFluorescence Polarization Immunoassay, Carbamazepine
Product CodeLGI
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionNeuroleptic Drugs Radioreceptor Assay Test System.
CFR Regulation Number862.3645 [🔎]
TPLC Last Update: 2019-04-02 21:19:03

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.