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Plasma, Control, Normal

FDA product code GIZ · Class 2 · Hematology

13
Registered devices
0
Adverse events
1
Recalls
20
510(k) clearances

Devices with this code

Berichrom® Heparin UF Control 1 — Siemens Healthcare Diagnostics Products GmbHPlasmaCon L2 — R 2 DIAGNOSTICS, INC.TriniCHECK™ D-Dimer 1 — TCOAG IRELAND LIMITEDCRYOcheck™ Reference Control Normal — Precision Biologic IncREAADS Coagulation Control 1 — CORGENIX MEDICAL CORPORATIONSTA® - Unicalibrator — DIAGNOSTICA STAGOPlasmaCon N — R 2 DIAGNOSTICS, INC.Coagulation S.A.C.-1 (Specialty Assay Control) — HELENA LABORATORIES CORPORATIONPlasmaCon L1 — R 2 DIAGNOSTICS, INC.Thermo Scientific Pacific Hemostasis® — Fisher DiagnosticsLAtrol NORMAL CONTROL PLASMA — Biomedica ADI Inc.CRYOcheck™ Reference Control Normal — Precision Biologic IncBerichrom® Heparin LMW Control 1 — Siemens Healthcare Diagnostics Products GmbH

Recent recalls

DateFirmReason
2019-11-18Diagnostica Stago, Inc.A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International St

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