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QUANTA Lite® tTG ELISA
INOVA DIAGNOSTICS, INC. · Model 708730 · UDI-DI 08426950594277
MVM
Prescription
1
510(k) clearances
2
Adverse events
1
Recalls
19
Facilities
Description
1. 1x tTG ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. x1 1.2mL prediluted tTG ELISA Low Positive 4. 1x 1.2mL prediluted tTG 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 |
|---|---|---|
| 2019-04-03 | Bio-Rad Labs | An elevated lot-to-lot bias was observed for Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA when compared to a previous lot of product. The observed elevated bias between th |
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