21 CFR 866.5510 — Immunoelectrophoretic, Immunoglobulins, (G, A, M)

Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5510

Identification

An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
CFFImmunoelectrophoretic, Immunoglobulins, (G, A, M)2293rd Party
CFNMethod, Nephelometric, Immunoglobulins (G, A, M)2613rd Party
CFQRadioimmunoassay, Immunoglobulins (G, A, M)2123rd Party
CGMMethod, Immunodiffusion, Immunoglobulins (G, A, M)243rd Party
CZJIgd, Antigen, Antiserum, Control283rd Party
CZKIga, Rhodamine, Antigen, Antiserum, Control213rd Party
CZLIga, Peroxidase, Antigen, Antiserum, Control203rd Party
CZMIga, Ferritin, Antigen, Antiserum, Control213rd Party
CZNIga, Fitc, Antigen, Antiserum, Control273rd Party
CZPIga, Antigen, Antiserum, Control2543rd Party
DAAIgg, Peroxidase, Antigen, Antiserum, Control253rd Party
DAFGamma Globulin, Fitc, Antigen, Antiserum, Control213rd Party
DAHGamma Globulin, Antigen, Antiserum, Control273rd Party
DEWIgg, Antigen, Antiserum, Control2763rd Party
DFMIge, Ferritin, Antigen, Antiserum, Control203rd Party
DFOIgg, Rhodamine, Antigen, Antiserum, Control203rd Party
DFZIgg (Gamma Chain Specific), Antigen, Antiserum, Control293rd Party
DGCIge, Antigen, Antiserum, Control21143rd Party
DGDIgg, Ferritin, Antigen, Antiserum, Control233rd Party
DGEIgd, Rhodamine, Antigen, Antiserum, Control223rd Party
DGGIgd, Fitc, Antigen, Antiserum, Control203rd Party
DGHIgd, Peroxidase, Antigen, Antiserum, Control213rd Party
DGKIgg, Fitc, Antigen, Antiserum, Control223rd Party
DGLIge, Rhodamine, Antigen, Antiserum, Control203rd Party
DGOIge, Peroxidase, Antigen, Antiserum, Control2153rd Party
DGPIge, Fitc, Antigen, Antiserum, Control243rd Party
JHRRadioimmunoassay, Immunoglobulins (D, E)293rd Party
KTSSecond Antibody (Species Specific Anti-Animal Gamma Globulin)243rd Party
MLHStrip, Hama Igg, Elisa, In Vitro Test System203rd Party
OPXImmunoglobulin A Kappa Heavy & Light Chain Combined233rd Party
OPYIgal Heavy & Light Chain Combined203rd Party
PCNImmunoglobulin G Kappa Heavy And Light Chain Combined233rd Party
PCOImmunoglobulin G Lambda Heavy And Light Chain Combined203rd Party
PDEImmunoglobulin M Kappa Heavy And Light Chain Combined223rd Party
PDFImmunoglobulin M Lambda Heavy And Light Chain Combined203rd Party
SGGMass Spectrometric, Immunoglobulins (G, A, M, D, E)21
Innolitics

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