Substance, Blood Grouping Of Non-human Origin For In Vitro Diagnostic Use

Device Code: 2406

Product Code(s): KSX

Device Classification Information

Device Type ID2406
Device NameSubstance, Blood Grouping Of Non-human Origin For In Vitro Diagnostic Use
Regulation DescriptionBlood Group Substances Of Nonhuman Origin For In Vitro Diagnostic Use.
Regulation Medical SpecialtyHematology
Review PanelHematology
Premarket Review Center For Biologics Evaluation & Research (CBER)
Submission Type510(K) Exempt
CFR Regulation Number864.9160 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeKSX
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2406
DeviceSubstance, Blood Grouping Of Non-human Origin For In Vitro Diagnostic Use
Product CodeKSX
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionBlood Group Substances Of Nonhuman Origin For In Vitro Diagnostic Use.
CFR Regulation Number864.9160 [🔎]
TPLC Last Update: 2019-04-02 20:11:19

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