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LupoTek Correctin VL

R 2 DIAGNOSTICS, INC. · Model 86-201 · UDI-DI 10859394006115

GIRGGC
1
510(k) clearances
4
Adverse events
1
Recalls
11
Facilities

Description

Venom Confirmatory test for LA 10 x 1 ml

Recalls

DateFirmReason
2007-02-28American Diagnostica, Inc.Stability of product not assured. An increase of clotting time for both normal and abnormal plasmas

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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.