Home › Device types › GGW
Test, Time, Partial Thromboplastin
FDA product code GGW · Class 2 · Hematology
30
Registered devices
79
Adverse events
4
Recalls
32
510(k) clearances
Devices with this code
ACTICLOT Protein C Resistance Kit — Biomedica ADI Inc.CRYOcheck™ Platelet Lysate — Precision Biologic IncCoatest APCR Control Plasma Level 1 — INSTRUMENTATION LABORATORY COMPANYLupoTek KCT — R 2 DIAGNOSTICS, INC.Dade Actin FS Activated PTT Reagent — Siemens Healthcare Diagnostics Products GmbHDade Actin FSL Activated PTT Reagent — Siemens Healthcare Diagnostics Products GmbHCoatest APC Resistance — INSTRUMENTATION LABORATORY COMPANYFactor V Leiden — Siemens Healthcare Diagnostics Products GmbHREAADS Anti-Cardiolipin IgG/IgM Semi-Quantitative Test Kit (96 Well) — CORGENIX MEDICAL CORPORATIONPTT-LA — DIAGNOSTICA STAGOPefakit — Pentapharm AGCoatest APC Resistance V-S — INSTRUMENTATION LABORATORY COMPANYPhospholin ES w/Calcium — R 2 DIAGNOSTICS, INC.Dade Actin FSL Activated PTT Reagent — Siemens Healthcare Diagnostics Products GmbHCoatest APC Resistance V — INSTRUMENTATION LABORATORY COMPANYSTA® - C.K. Prest® 5 — DIAGNOSTICA STAGOHemosIL Factor V Leiden (APC Resistance V) — INSTRUMENTATION LABORATORY COMPANYDade® Actin® FS Activated PTT Reagent — Siemens Healthcare Diagnostics Products GmbHSTA® - PTT A 5 — DIAGNOSTICA STAGODade® Actin® FS Activated PTT Reagent — Siemens Healthcare Diagnostics Products GmbHPTT-LA — DIAGNOSTICA STAGOPhospholin ES w/ Calcium Chloride — R 2 DIAGNOSTICS, INC.Coatest APCR Control Plasma Level 2 — INSTRUMENTATION LABORATORY COMPANYAB-TROL 2 Coagulation Control — HELENA LABORATORIES CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2013-03-11 | Siemens Healthcare Diagnostics, Inc. | Siemens has observed that the listed lot numbers show an increase in Heparin sensitivity over the shelf life which is demonstrated by testing with Dade(R) Citro |
| 2011-12-19 | Siemens Healthcare Diagnostics, Inc. | The listed lots of Dade(R) Actin(R) FSL Reagent show an increase in Heparin sensitivity over the shelf life which is demonstrated by testing with Dade(R) Citrol |
| 2005-09-23 | Dade Behring , Inc. | prolonged aPTT results |
| 2005-04-13 | Diagnostica Stago, Inc. | Variable clotting times observed with the PTT-LA, Lupus Anticoagulant-Sensitive APTT Reagent. |
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