Hemagglutination Inhibition, Methadone

Device Code: 6034

Product Code(s): DIW

Device Classification Information

Device Type ID6034
Device NameHemagglutination Inhibition, Methadone
Regulation DescriptionMethadone Test System.
Regulation Medical SpecialtyToxicology
Review PanelToxicology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number862.3620 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeDIW
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID6034
DeviceHemagglutination Inhibition, Methadone
Product CodeDIW
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionMethadone Test System.
CFR Regulation Number862.3620 [🔎]
TPLC Last Update: 2019-04-02 21:16:20

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