Radioimmunoassay, Immunoglobulins (g, A, M)

Device Code: 2874

Product Code(s): CFQ

Device Classification Information

Device Type ID2874
Device NameRadioimmunoassay, Immunoglobulins (g, A, M)
Regulation DescriptionImmunoglobulins A, G, M, D, And E Immunological Test System.
Regulation Medical SpecialtyImmunology
Review PanelImmunology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number866.5510 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeCFQ
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 ID2874
DeviceRadioimmunoassay, Immunoglobulins (g, A, M)
Product CodeCFQ
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionImmunoglobulins A, G, M, D, And E Immunological Test System.
CFR Regulation Number866.5510 [🔎]
Device Problems
High Test Results
7
Low Test Results
3
Probe
2
Incorrect Or Inadequate Test Results
2
Seal
1
Device Component Or Accessory
1
Total Device Problems 16
TPLC Last Update: 2019-04-02 20:20:26

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