Glucose-6-phosphate Dehydrogenase (erythrocytic), Spot

Device Code: 2329

Product Code(s): JBG

Device Classification Information

Device Type ID2329
Device NameGlucose-6-phosphate Dehydrogenase (erythrocytic), Spot
Regulation DescriptionErythrocytic Glucose-6-phosphate Dehydrogenase Assay.
Regulation Medical SpecialtyHematology
Review PanelHematology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number864.7360 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeJBG
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 ID2329
DeviceGlucose-6-phosphate Dehydrogenase (erythrocytic), Spot
Product CodeJBG
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionErythrocytic Glucose-6-phosphate Dehydrogenase Assay.
CFR Regulation Number864.7360 [🔎]
TPLC Last Update: 2019-04-02 20:09:52

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