Breast Milk, Rhodamine, Antigen, Antiserum, Control

Device Code: 2987

Product Code(s): DGI

Device Classification Information

Device Type ID2987
Device NameBreast Milk, Rhodamine, Antigen, Antiserum, Control
Regulation DescriptionBreast Milk Immunological Test System.
Regulation Medical SpecialtyImmunology
Review PanelImmunology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number866.5170 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeDGI
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2987
DeviceBreast Milk, Rhodamine, Antigen, Antiserum, Control
Product CodeDGI
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionBreast Milk Immunological Test System.
CFR Regulation Number866.5170 [🔎]
TPLC Last Update: 2019-04-02 20:22:09
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