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AESKULISA tTg-A New Generation
Aesku.Diagnostics GmbH & Co. KG · Model 7503US · UDI-DI 04250289503129
1
510(k) clearances
2
Adverse events
1
Recalls
19
Facilities
Description
The AESKULISA tTg-A New generation is a solid phase enzyme immunoassay for the quantitative and qualitative detection of IgA antibodies against neo-epitopes of tissue transglutaminase (tTG) in human serum.
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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