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QUANTA Lite® aPS/PT IgM ELISA

INOVA DIAGNOSTICS, INC. · Model 708845 · UDI-DI 08426950594796

OPN Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

(anti-phosphatidylserine and prothrombin) 1. 1 aPS/PT IgM ELISA microwell plate (12-1 x 8 wells), with holder 2. 1 1.2mL prediluted ELISA Negative Control 3. 1 1.2mL prediluted aPS/PT IgM ELISA Control 4. 1 1.2mL prediluted aPS/PT IgM ELISA Calibrator A 5. 1 1.2mL prediluted aPS/PT IgM ELISA Calibrator B 6. 1 1.2mL prediluted aPS/PT IgM ELISA Calibrator C 7. 1 1.2mL prediluted aPS/PT IgM ELISA Calibrator D 8. 1 1.2mL prediluted aPS/PT IgM ELISA Calibrator E 9. 1 10mL HRP aPS/PT IgM Conjugate, (goat), anti-human IgM 10. 1 50mL HRP Sample Diluent Plus 11. 1 25mL HRP Wash Buffer Plus, 40x concentrate 12. 1 10mL TMB Chromogen 13. 1 10mL HRP Stop Solution, 0.344M Sulfuric Acid

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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.