Radioimmunoassay, Digoxin (125-i), Goat Antibody, 2nd Antibody Sep.

Device Code: 6105

Product Code(s): DNJ

Device Classification Information

Device Type ID6105
Device NameRadioimmunoassay, Digoxin (125-i), Goat Antibody, 2nd Antibody 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 CodeDNJ
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 ID6105
DeviceRadioimmunoassay, Digoxin (125-i), Goat Antibody, 2nd Antibody Sep.
Product CodeDNJ
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionDigoxin Test System.
CFR Regulation Number862.3320 [🔎]
TPLC Last Update: 2019-04-02 21:17:21

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