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Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
FDA product code NQN · Class 2 · Hematology
44
Registered devices
5
Adverse events
4
Recalls
15
510(k) clearances
Devices with this code
Leica Biosystems Ariol DM6000 B Basic Configuration Ariol — Leica Biosystems Richmond, Inc.Leica Biosystems Ariol Rare Event Module — Leica Biosystems Richmond, Inc.VIRTUOSO System for IHC — VENTANA MEDICAL SYSTEMS, INC.Leica Biosystems Ariol Fluorescent Unit — Leica Biosystems Richmond, Inc.GenASIs™ System — APPLIED SPECTRAL IMAGING LTD.Leica Biosystems Ariol 200 Slide loader — Leica Biosystems Richmond, Inc.Leica Biosystems Ariol IHC Module — Leica Biosystems Richmond, Inc.Leica Biosystems Ariol DM6000B Workstation — Leica Biosystems Richmond, Inc.eIHC IVD bundle AT Turbo-2500 — LEICA BIOSYSTEMS IMAGING, INCASI IVD System — APPLIED SPECTRAL IMAGING LTD.Leica Biosystems Ariol Large Stage 8 slides — Leica Biosystems Richmond, Inc.Leica Biosystems Ariol Y and Z Axis Drive Belts (2 Belts),SL200 — Leica Biosystems Richmond, Inc.Leica Biosystems Lamp Housing 107, 12V 100W, 1 Lens — Leica Biosystems Richmond, Inc.Leica Biosystems Ariol General Analysis Module — Leica Biosystems Richmond, Inc.Leica Biosystems Ariol Slide Exporter (SCN for DIH) — Leica Biosystems Richmond, Inc.Leica Biosystems Ariol DM6000 B Basic Configuration Ariol Refurbished — Leica Biosystems Richmond, Inc.Leica Biosystems Ariol DM6000 B for Ariol PL200 Refurbished — Leica Biosystems Richmond, Inc.Leica Biosystems Ariol Beveled Edge Slide Holder — Leica Biosystems Richmond, Inc.Leica Biosystems Ariol Leica DM6000B Ariol — Leica Biosystems Richmond, Inc.Leica Biosystems Ariol PL220 Automatic Oiler — Leica Biosystems Richmond, Inc.Leica Biosystems Ariol Camera Small, Jai CVM4 — Leica Biosystems Richmond, Inc.Leica Biosystems Ariol Fluorescent Module — Leica Biosystems Richmond, Inc.ASI IVD System — APPLIED SPECTRAL IMAGING LTD.Leica Biosystems Ariol SCN400 Review Station — Leica Biosystems Richmond, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-11-23 | Roche Molecular Systems, Inc. | When a user creates a measurement tool annotation in the uPath Enterprise software version 1.1, the measurement value is incorrectly calculated when the measure |
| 2016-05-06 | Leica Biosystems Richmond Inc. | An issue during the manufacturing process caused systems to have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated with |
| 2008-11-06 | Leica Microsystems, Inc. | A change in the software to open up the software architecture to include other analytes other than Estrogen Receptor was made without FDA review and approval. |
| 2007-06-26 | Ventana Medical Systems Inc | Incomplete upgrade: The software upgrade from February 1, 2007 may not have been completed. This software upgrade adds the algorithm (Slidetype) for the PATHWA |
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