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REAADS Anti-dsDNA Test Kit

FDA UDI

Class II (US FDA UDI)

by Corgenix Medical Corporation

Identity

Trade Name
REAADS Anti-dsDNA Test Kit FDA UDI
Generic Name
Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
INTENDED USE Anti-dsDNA is an indirect solid phase enzyme immunoassay (ELISA) for the quantitative measurement of IgG class autoantibodies against double-stranded DNA in human serum or plasma. The assay is intended as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE). For In Vitro Diagnostic Use. SUMMARY OF THE TEST Autoimmune diseases are characterized by the occurence of antibodies against one’s own antigenic structures, also known as autoantibodies. Presence of autoantibodies to native desoxyribonucleic acids (n-DNA, dsDNA, double-stranded DNA) is typical for the clinical picture of SLE. Antibodies against dsDNA belong to the group of Anti Nuclear Antibodies (ANA), which are directed against various structures of the nucleus of the cell. They appear in a variety of rheumatoid diseases. Antibodies to dsDNA are found during the active phases of SLE. Diagnostic sensitivity of the anti-dsDNA determination in cases of SLE is approximately 91 % combined with a diagnostic specificity of nearly 96 percent. SLE like diseases are caused by some drugs. For differential diagnosis of drug-induced SLE the determination of anti-dsDNA is a valuable diagnostic tool. PRINCIPLE OF THE TEST Human recombinant double-stranded DNA (dsDNA) is bound to microwells. Antibodies to this antigen bind to the respective antigen. Washing of the microwells removes unspecific serum/plasma components. Horseradish peroxidase (HRP) conjugated anti-human IgG immunologically detects the bound patient antibodies forming a conjugate/antibody/antigen complex. Washing of the microwells removes unbound conjugate. An enzyme substrate in the presence of bound conjugate hydrolyzes to form a blue color. The addition of an acid stops the reaction forming a yellow color in the test well which is measured photometrically at 450 nm. The amount of color is directly proportional to the concentration of IgG antibodies present in the original sample. Refer to Product Package Insert. FDA UDI
Model / Reference
13086 FDA UDI
Description
INTENDED USE Anti-dsDNA is an indirect solid phase enzyme immunoassay (ELISA) for the quantitative measurement of IgG class autoantibodies against double-stranded DNA in human serum or plasma. The assay is intended as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE). For In Vitro Diagnostic Use. SUMMARY OF THE TEST Autoimmune diseases are characterized by the occurence of antibodies against one’s own antigenic structures, also known as autoantibodies. Presence of autoantibodies to native desoxyribonucleic acids (n-DNA, dsDNA, double-stranded DNA) is typical for the clinical picture of SLE. Antibodies against dsDNA belong to the group of Anti Nuclear Antibodies (ANA), which are directed against various structures of the nucleus of the cell. They appear in a variety of rheumatoid diseases. Antibodies to dsDNA are found during the active phases of SLE. Diagnostic sensitivity of the anti-dsDNA determination in cases of SLE is approximately 91 % combined with a diagnostic specificity of nearly 96 percent. SLE like diseases are caused by some drugs. For differential diagnosis of drug-induced SLE the determination of anti-dsDNA is a valuable diagnostic tool. PRINCIPLE OF THE TEST Human recombinant double-stranded DNA (dsDNA) is bound to microwells. Antibodies to this antigen bind to the respective antigen. Washing of the microwells removes unspecific serum/plasma components. Horseradish peroxidase (HRP) conjugated anti-human IgG immunologically detects the bound patient antibodies forming a conjugate/antibody/antigen complex. Washing of the microwells removes unbound conjugate. An enzyme substrate in the presence of bound conjugate hydrolyzes to form a blue color. The addition of an acid stops the reaction forming a yellow color in the test well which is measured photometrically at 450 nm. The amount of color is directly proportional to the concentration of IgG antibodies present in the original sample. Refer to Product Package Insert. FDA UDI

Identifiers

Catalog Number
13086 FDA UDI
Primary DI / UDI-DI
00855360006205 FDA UDI
FDA Product Code
LRM FDA UDI
GMDN Term
Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5100 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA)

REAADS Anti-dsDNA Test Kit by Corgenix Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Corgenix Medical Corporation

Sources (1)

  • FDA UDI 5341db7b-76f5-434c-a313-c2d85619d565 36 fields · synced May 30, 2026