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AESKULISA® ß2-Glyco-GM
Aesku.Diagnostics GmbH & Co. KG · Model 3206 · UDI-DI 04250289500869
1
510(k) clearances
0
Adverse events
1
Recalls
18
Facilities
Description
AESKULISA β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the separate quantitative and qualitative detection of IgG and / or IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein 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 (APS).
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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