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Gliadin IgG ELISA
DRG Instruments Gesellschaft mit beschränkter Haftung · Model EIA-3371 · UDI-DI 04048474033717
MST
Prescription
1
510(k) clearances
0
Adverse events
3
Recalls
20
Facilities
Description
The DRG Gliadin IgG ELISA test system is intended for the qualitative and semi-quantitative detection of IgG-class antibodies to gliadin in human serum. The test system is intended to be used as an aid in the diagnosis of gastrointestinal disorders, mainly Celiac Disease
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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