Stains, Heinz Body

Device Code: 2294

Product Code(s): GJJ

Device Classification Information

Device Type ID2294
Device NameStains, Heinz Body
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 CodeGJJ
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2294
DeviceStains, Heinz Body
Product CodeGJJ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionDye And Chemical Solution Stains.
CFR Regulation Number864.1850 [🔎]
TPLC Last Update: 2019-04-02 20:09:03

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