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Sign in to claim this brandLeica Biosystems Imaging, Inc.
United States·US-MF-000020547
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 1360, Park Center Drive, Vista, United States
- Website
- LeicaBiosystems.com
- —
- —
- [email protected]
- Phone
- +1 866 478 9520
- PRRC Contact
- April Komplin
- EUDAMED SRN
- US-MF-000020547
- FDA FEI Number
- 3006791373
- DUNS Number
- —
Catalogue (49)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Aperio AT2 DX Scanner | 23AT2DX | FDA UDI | Class II | Active |
| eIHC IVD bundle CS2- 2500 | 23CS2IVD-2500 | FDA UDI | Class II | Active |
| eIHC IVD bundle AT Turbo-2500 | 23ATTIVD-2500 | FDA UDI | Class II | Active |
| Aperio GT 450 DX (US) Scanner | 23GT450DXUS | FDA UDI | Class II | Active |
| Leica DM 91024 DAPI | 232FL4900072DX | EUDAMED | Class A | Active |
| GSL Workstation for BF and Fluorescence | 23GSLCPUBFFDX | EUDAMED | Class A | Active |
| OBJ HC PL FLUOTAR 40x/0.80 | 23OBJ040PLFDRYDX | EUDAMED | Class A | Active |
| Leica DM 91024 RED | 232FL4930672DX | EUDAMED | Class A | Active |
| Karyotyping Review Station | 23REV001BFX230DX | EUDAMED | Class A | Active |
| Leica DM 91024 Green / Red Dual | 232FL5901072DX | EUDAMED | Class A | Active |
| Aperio GT 180 DX | 23GT180DXIVD | EUDAMED | Class A | Active |
| Aperio AT2 DX System | K190332 | FDA 510(k) | Class II | Active |
| Aperio Epathology Eihc Ivd System | K141109 | FDA 510(k) | Class II | Active |
| Leica DM 91024 O/G/A Triple | 232FL6901172DX | EUDAMED | Class A | Active |
| MFISH Software (requires Karyotyping and FISH Capabilities) | 23SWRMFXDX | EUDAMED | Class A | Active |
| Aperio HALO AP | 23HALOAP | EUDAMED | Class A | Active |
| Karyotyping and FISH Review Station | 23REV001BFF230DX | EUDAMED | Class A | Active |
| Obj Hc Pl Fl 100x Oil | 23OBJ100PLFOILDX | EUDAMED | Class A | Active |
| Karyotyping Review Software (incl Dongle) | 23SWRBFXDX | EUDAMED | Class A | Active |
| Karyo FISH Station with Camera (without Microscope) | 23CAP002BFF230DX | EUDAMED | Class A | Active |
| Karyo FISH Station with Microscope and CameraCamera | 23CAP001BFF230DX | EUDAMED | Class A | Active |
| Aperio GT 450 SAM DX Software | 23SAMSWDXIVD | EUDAMED | Class A | Active |
| Obj Hc Pl Apo 63x Oil | 23OBJ063PAPOIL01DX | EUDAMED | Class A | Active |
| Aperio SAM DX | 23APERIOSAMSWDX1 | EUDAMED | Class A | Active |
| GSL120 scan system BF FL | 23GSL120BFF230DX | EUDAMED | Class A | Active |
| Obj Hc Pl Fl 63x Oil | 23OBJ063PLFOILDX | EUDAMED | Class A | Active |
| GSL Workstation for BF | 23GSLCPUBFXDX | EUDAMED | Class A | Active |
| Karyotyping and FISH Review Software (incl Dongle) | 23SWRBFFDX | EUDAMED | Class A | Active |
| Leica DM 91024 Orange / Green / DAPI Triple | 232FL6901372DX | EUDAMED | Class A | Active |
| Obj Hc Pl Apo 100x Oil | 23OBJ100PAPOILDX | EUDAMED | Class A | Active |
| Aperio CS5 DX | 23CS5DXIVD | EUDAMED | Class A | Active |
| Leica DM 91024 CY5 (Far Red) | 232FL4900972DX | EUDAMED | Class A | Active |
| Leica DM 91024 GREEN#1 (AVOIDS AQUA) | 232FL4930372DX | EUDAMED | Class A | Active |
| Leica DM 91024 GREEN #2 (AVOIDS GOLD) | 232FL4930872DX | EUDAMED | Class A | Active |
| Leica DM 91024 NARROW RED | 232FL4931172DX | EUDAMED | Class A | Active |
| Leica DM 91024 GOLD | 232FL4930472DX | EUDAMED | Class A | Active |
| Karotyping Capture Workstation | 23CAPUPSBFXDX | EUDAMED | Class A | Active |
| Leica DM 91024 ORANGE | 232FL4930572DX | EUDAMED | Class A | Active |
| CytoVision DX | 23GSL10XBFF230DX | EUDAMED | Class A | Active |
| Aperio iQC DX | 23iQCDXROW | EUDAMED | Class A | Active |
| Leica DM 91024 AQUA | 232FL4930272DX | EUDAMED | Class A | Active |
| Karyo Station with Camera (without Microscope) | 23CAP003BFX230DX | EUDAMED | Class A | Active |
| Karotyping and FISH Capture Workstations | 23CAPUPSBFFDX | EUDAMED | Class A | Active |
| Aperio GT 450 DX | 23GT450DXIVD | EUDAMED | Class A | Active |
| Aperio WebViewer DX | 23WVROWIVD | EUDAMED | Class A | Active |
| Karyo Station with Microscope and Camera | 23CAP001BFX230DX | EUDAMED | Class A | Active |
| GSL10 scan system BF | 23GSL10XBFX230DX | EUDAMED | Class A | Active |
| Tissue FISH Software and Joystick - Scan System Only | 23SWRTFHDX | EUDAMED | Class A | Active |
| Leica DM 91024 Green / Orange Dual | 232FL5901172DX | EUDAMED | Class A | Active |
Related Companies
Authorised Representatives
- CEpartner4U NL
- CEpartner4U NL
Importers
Not available yet.
Notified Bodies
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Authorities
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Dec 10, 2018 | Z-0046-2020 | — | terminated | The incorrect sensor was used in the assembly of the camera in the scanner instrument which can potentially generate whole slide images that impact analysis algorithm results, as well as potentially impact the visual appearance of whole slide images. |
| Feb 7, 2014 | Z-1152-2014 | — | terminated | In an abundance of caution, Aperio (now known as Lecia Biosystems) is providing additional information to clarify that the use of Digital IHC Breast/ER/Dako Image Analysis, Digital IHC Breast/HER2 Digital Read, Digital IHC Breast/HER2/Dako Image Analysis, Digital IHC Breast/PR Digital Read and Digital IHC Breast/PR/Dako Image Analysis with the RUO products identified in that earlier notification i |