Digoxin Control Serum, Ria

Device Code: 6092

Product Code(s): DMP

Device Classification Information

Device Type ID6092
Device NameDigoxin Control Serum, Ria
Regulation DescriptionClinical Toxicology Control Material.
Regulation Medical SpecialtyToxicology
Review PanelToxicology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number862.3280 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeDMP
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 ID6092
DeviceDigoxin Control Serum, Ria
Product CodeDMP
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionClinical Toxicology Control Material.
CFR Regulation Number862.3280 [🔎]
TPLC Last Update: 2019-04-02 21:17:11

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