Radioimmunoassay, Lsd (125-i)

Device Code: 6071

Product Code(s): DLB

Device Classification Information

Device Type ID6071
Device NameRadioimmunoassay, Lsd (125-i)
Regulation DescriptionLysergic Acid Diethylamide (LSD) Test System.
Regulation Medical SpecialtyToxicology
Review PanelToxicology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number862.3580 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeDLB
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 ID6071
DeviceRadioimmunoassay, Lsd (125-i)
Product CodeDLB
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionLysergic Acid Diethylamide (LSD) Test System.
CFR Regulation Number862.3580 [🔎]
TPLC Last Update: 2019-04-02 21:16:51

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