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QUANTA Lite® PR3 SC ELISA Bulk Pack

INOVA DIAGNOSTICS, INC. · Model 704660.10 · UDI-DI 08426950594550

MOB Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

1 .Instruction leaflet: Giving full assay details. 2.QC Certificate: Indicating the expected performance of the batch. 3. PR3 SC Coated Wells: 10 plates containing 12 breakapart 8 well strips coated with PR3 antigen, colour coded red. Each plate is packaged in a re-sealable foil bag containing 2 desiccant pouches. 4.Type III Sample Diluent: 19 bottles containing 50mL of buffer for sample dilution. Coloured yellow, ready to use. 5. HRP Wash Concentrate: 10 bottles containing 25mL of a 40-fold concentrated buffer for washing the wells. 6. PR3 SC ELISA Calibrators: 25 bottles (5 bottles each) containing 1.2mL of diluted human serum, with the following concentrations of anti-PR3 autoantibody: 100, 33.3, 11.1, 3.7, 1.23 U/mL. Ready to use. 7. PR3 SC Positive Control: 5 bottles containing 1.2mL of diluted human serum. Ready to use. 8.ELISA Negative Control: 5 bottles containing 1.2mL of diluted human serum. Ready to use. 9. HRP PR3 SC IgG Conjugate: 10 bottles containing 10mL of purified peroxidase labelled antibody to human IgG. Coloured blue, ready to use. 10.TMB Chromogen: 10 bottles containing 10mL TMB substrate. Ready to use. 11. HRP Stop Solution: 10 bottles containing 10mL of 0.344M Sulfuric acid. Ready to use.

Recalls

Date	Firm	Reason
2023-05-24	Phadia Ab	Complaints that specific samples produced false positive EliA GBM results. A positive signal was present when these samples were tested for coating-solution reactivity using EliA w

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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.