Stain, Reticulocyte

Device Code: 2293

Product Code(s): GJH

Device Classification Information

Device Type ID2293
Device NameStain, Reticulocyte
Regulation DescriptionDye And Chemical Solution Stains.
Regulation Medical SpecialtyHematology
Review PanelHematology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number864.1850 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeGJH
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2293
DeviceStain, Reticulocyte
Product CodeGJH
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionDye And Chemical Solution Stains.
CFR Regulation Number864.1850 [🔎]
TPLC Last Update: 2019-04-02 20:09:02

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