FDA Device Intelligence
Home › Device types › GIZ

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

PlasmaCon L2 — R 2 DIAGNOSTICS, INC.TriniCHECK™ D-Dimer 1 — TCOAG IRELAND LIMITEDSTA® - Unicalibrator — DIAGNOSTICA STAGOPlasmaCon L1 — R 2 DIAGNOSTICS, INC.REAADS Coagulation Control 1 — CORGENIX MEDICAL CORPORATIONPlasmaCon N — R 2 DIAGNOSTICS, INC.LAtrol NORMAL CONTROL PLASMA — Biomedica ADI Inc.CRYOcheck™ Reference Control Normal — Precision Biologic IncThermo Scientific Pacific Hemostasis® — Fisher DiagnosticsCRYOcheck™ Reference Control Normal — Precision Biologic IncBerichrom® Heparin UF Control 1 — Siemens Healthcare Diagnostics Products GmbHCoagulation S.A.C.-1 (Specialty Assay Control) — HELENA LABORATORIES CORPORATIONBerichrom® 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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.