Research Use Only/hematology Devices

Device Code: 2502

Product Code(s): OTQ

Definition: For Research Use Only And For Products Imported Into The US Only.

Device Classification Information

Device Type ID2502
Device NameResearch Use Only/hematology Devices
Physical StateN/A
Technical MethodN/A
Target AreaN/A
Review PanelHematology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission TypeEnforcement Discretion
FDA Device ClassificationClass Not Classified Medical Device
Product CodeOTQ
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2502
DeviceResearch Use Only/hematology Devices
Product CodeOTQ
TPLC Last Update: 2019-04-02 20:13:25

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