Test, Leukocyte Peroxidase

Device Code: 4761

Product Code(s): GIA

Device Classification Information

Device Type ID4761
Device NameTest, Leukocyte Peroxidase
Regulation DescriptionLeukocyte Peroxidase Test.
Regulation Medical SpecialtyHematology
Review PanelPathology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number864.7675 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeGIA
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4761
DeviceTest, Leukocyte Peroxidase
Product CodeGIA
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionLeukocyte Peroxidase Test.
CFR Regulation Number864.7675 [🔎]
Device Problems
Mechanical Jam
1
Mechanics Altered
1
Failure To Fire
1
Total Device Problems 3
TPLC Last Update: 2019-04-02 20:55:14

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