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Last synced on 18 April 2025 at 11:05 pm
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subpart-f—immunological-test-systems/
NYO
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Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody

Page Type
Product Code
Definition
The anti-rna polymerase iii test is a semi-quantitative elisa for the detection of anti-rna polymerase iii antibodies in human serum. The test result is used as an aid in the diagnosis of systemic sclerosis (ssc) in conjunction with the clinical and other laboratory findings. For in-vitro diagnostic use.
Physical State
Antibody ELISA kit, Antigen and Controls
Technical Method
The ELISA test result aids in the diagnosis of Systemic Sclerosis (SSc)
Target Area
Blood Serum
Regulation Medical Specialty
Immunology
Review Panel
Immunology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
866.5100
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 § 866.5100 Antinuclear antibody immunological test system

§ 866.5100 Antinuclear antibody immunological test system.

(a) Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).

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

FDA Browser

by Innolitics

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

Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody

Page Type
Product Code
Definition
The anti-rna polymerase iii test is a semi-quantitative elisa for the detection of anti-rna polymerase iii antibodies in human serum. The test result is used as an aid in the diagnosis of systemic sclerosis (ssc) in conjunction with the clinical and other laboratory findings. For in-vitro diagnostic use.
Physical State
Antibody ELISA kit, Antigen and Controls
Technical Method
The ELISA test result aids in the diagnosis of Systemic Sclerosis (SSc)
Target Area
Blood Serum
Regulation Medical Specialty
Immunology
Review Panel
Immunology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
866.5100
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible
View Source

CFR § 866.5100 Antinuclear antibody immunological test system

§ 866.5100 Antinuclear antibody immunological test system.

(a) Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).

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