Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Coated Tube Sep.

Device Code: 6146

Product Code(s): DPO

Device Classification Information

Device Type ID6146
Device NameRadioimmunoassay, Digoxin (125-i), Rabbit Antibody, Coated Tube Sep.
Regulation DescriptionDigoxin Test System.
Regulation Medical SpecialtyToxicology
Review PanelToxicology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number862.3320 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeDPO
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 ID6146
DeviceRadioimmunoassay, Digoxin (125-i), Rabbit Antibody, Coated Tube Sep.
Product CodeDPO
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionDigoxin Test System.
CFR Regulation Number862.3320 [🔎]
TPLC Last Update: 2019-04-02 21:17:54

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