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Last synced on 18 April 2025 at 11:05 pm
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subpart-f—immunological-test-systems/
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Immunoglobulin M Lambda Heavy And Light Chain Combined

Page Type
Product Code
Definition
Intended for the in-vitro quantification of IgM lambda concentration in human serum. The result is to be used with previously diagnosed IgM Waldenstoms Macrolobulinaemia, in conjunction with other clinical and laboratory findings.
Physical State
Kit is composed of polyclonal monospecific sheep anti-IgM lambda antibody, IgM lambda Calibrator, 2 IgM lambda Controls, and IgM lambda Supplementary Reagent
Technical Method
Nephelometric immunoassay method
Target Area
Peripheral human blood, serum
Regulation Medical Specialty
Immunology
Review Panel
Immunology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
866.5510
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible
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CFR § 866.5510 Immunoglobulins A, G, M, D, and E immunological test system

§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.

(a) 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.

(b) Classification. Class II (performance standards).

FDA Browser

by Innolitics

IM/
subpart-f—immunological-test-systems/
PDF
View Source

Immunoglobulin M Lambda Heavy And Light Chain Combined

Page Type
Product Code
Definition
Intended for the in-vitro quantification of IgM lambda concentration in human serum. The result is to be used with previously diagnosed IgM Waldenstoms Macrolobulinaemia, in conjunction with other clinical and laboratory findings.
Physical State
Kit is composed of polyclonal monospecific sheep anti-IgM lambda antibody, IgM lambda Calibrator, 2 IgM lambda Controls, and IgM lambda Supplementary Reagent
Technical Method
Nephelometric immunoassay method
Target Area
Peripheral human blood, serum
Regulation Medical Specialty
Immunology
Review Panel
Immunology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
866.5510
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible
View Source

CFR § 866.5510 Immunoglobulins A, G, M, D, and E immunological test system

§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.

(a) 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.

(b) Classification. Class II (performance standards).