REAADS Anti-dsDNA Test Kit 13086

GUDID 00855360006205

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.

CORGENIX MEDICAL CORPORATION

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

• Primary Device ID: 00855360006205
• NIH Device Record Key: 5341db7b-76f5-434c-a313-c2d85619d565
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REAADS Anti-dsDNA Test Kit
• Version Model Number: 13086
• Catalog Number: 13086
• Company DUNS: 619834542
• Company Name: CORGENIX MEDICAL CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-729-5661
• Email: technicalsupport@corgenix.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855360006205 [Primary]

FDA Product Code

• LRM: Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-07-14

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