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QUANTA Lite® β2GPI IgG ELISA

INOVA DIAGNOSTICS, INC. · Model 708665 · UDI-DI 08426950451112

MSV Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted 2 GPI IgG ELISA Control 4. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator A 5. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator B 6. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator C 7. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator D 8. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator E 9. 1x 50mL HRP Sample Diluent 10. 1x 25mL HRP Wash Concentrate, 40x concentrate 11. 1x 10mL 2 HRP IgG Conjugate, (goat), anti-human IgG 12. 1x 10mL TMB Chromogen 13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid

Recalls

Date	Firm	Reason
2004-10-26	Diasorin Inc.	Data reduction Program written for specific sutomated microtiter plate insturment (Bio-Tek ELx800 reader) is faulty in that the positive result limit is to be greater than 15 U/ml,

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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.