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QUANTA Lite® dsDNA SC ELISA

INOVA DIAGNOSTICS, INC. · Model 704650 · UDI-DI 08426950544111

LRM Prescription

510(k) clearances

109

Adverse events (2 deaths)

Recalls

Facilities

Description

1.Instruction leaflet: Giving full assay details. 2. QC Certificate: Indicating the expected performance of the batch. 3. dsDNA SC Coated Wells: 12 breakapart 8 well strips coated with calf thymus dsDNA antigen. Each plate is packaged in a re-sealable foil bag containing two desiccant pouches. 4. ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use. 5. dsDNA SC Calibrators: 5 bottles, each containing 1.2mL of diluted human serum, with the following concentrations of anti-dsDNA autoantibody: 1000, 333, 111, 37, 12.3 IU/mL. Ready to use. 6. dsDNA SC Positive Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use. 7. Type III Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Colored yellow, ready to use. 8. HRP Wash Concentrate (40X): 1 bottle containing 25mL of a 40-fold concentrated buffer for washing the wells. 9.dsDNA SC Single Stranded Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use. 10. HRP dsDNA SC IgG Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgG. Colored blue. Ready to use. 11. TMB Chromogen: 1 bottle containing 10mL TMB chromogen. Ready to use. 12. HRP Stop Solution: 1 bottle containing 10mL of 0.344M Sulfuric Acid. Ready to use.

Recalls

Date	Firm	Reason
2010-03-02	Bio-Rad Laboratories Inc	The firm received customer complaints of increased positivity rates associated with the Anti-dsDNA test kits.
2010-03-02	Bio-Rad Laboratories Inc	The firm received customer complaints of increased positivity rates associated with the Anti-dsDNA test kits.
2008-08-27	Calbiotech Inc	The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall,

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.