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AESKULISA® ß2-Glyco-A
Aesku.Diagnostics GmbH & Co. KG · Model 3205 · UDI-DI 04250289500852
1
510(k) clearances
0
Adverse events
1
Recalls
18
Facilities
Description
AESKULISA β2 Glyco-A is a solid phase enzyme immunoassay employing native β2 glycoprotein I highly purified from human plasma for the quantitative and qualitative detection of IgA antibodies against β2 glycoprotein I in human serum. Anti-β2 glycoprotein I antibodies recognize specific epitopes on human β2 glycoprotein I which are expressed only when β2 glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome.
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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