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DIASTAT anti-B2 Glycoprotein-1 IgG

Svar Life Science AB · Model FBGP200 · UDI-DI 07340058410141

MSV
10
510(k) clearances
0
Adverse events
1
Recalls
18
Facilities

Recalls

DateFirmReason
2004-10-26Diasorin 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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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.