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QUANTA Lite® Gliadin IgA II ELISA
INOVA DIAGNOSTICS, INC. · Model 704525 · UDI-DI 08426950448334
1
510(k) clearances
0
Adverse events
3
Recalls
20
Facilities
Description
1. 1x Gliadin IgA II ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted Gliadin IgA II ELISA Low Positive 4. 1x.2mL prediluted Gliadin IgA II ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgA Conjugate, (goat), anti-human IgA 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-05-01 | Phadia US Inc | Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250 instrument |
| 2023-05-01 | Phadia US Inc | Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250 instrument |
| 2008-03-21 | Diamedix Corporation | Standards and controls in the Is-anti-Gliadin IgG Test Kits are exhibiting low activity. A drop in the O.D.s the Positive Control could potentially recover low out of range (which |
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