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Leica Biosystems Richmond, Inc.

United States·US-MF-000014614

Last updated September 17, 2026

Information

Country: United States
Address: 5205, US Route 12, Richmond, United States
Website: leicabiosystems.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Heloiza Chirnev
EUDAMED SRN: US-MF-000014614
FDA FEI Number: 1419341
DUNS Number: —

Catalogue (583)

Page 2 of 12

Device	Model / Reference	Registries	Class	Status
Leica Biosystems	3802731	FDA UDI	Class I	Active
Leica Biosystems	39LC-675-1-500	FDA UDI	Class I	Active
Leica Biosystems CytoVision DM5000 B ERGO Head Version	23MIC1207	FDA UDI	Class II	Unknown
Leica Biosystems Ariol DM6000 B Ariol PL200	23MIC1206	FDA UDI	Class II	Active
Leica Biosystems	000000000003801575	FDA UDI	Class I	Active
Leica Biosystems	39LC-500-11-L	FDA UDI	Class I	Active
Leica Biosystems	000000000038441508	FDA UDI	Class I	Active
Leica Biosystems	39LC-580-1-L	FDA UDI	Class I	Active
Leica Biosystems	39LC-605-2-L	FDA UDI	Class I	Active
Leica Biosystems	39LC-500-8-L	FDA UDI	Class I	Active
Leica CAMERA, JAI CV-M4	23CAM0011R	FDA UDI	Class II	Unknown
Leica Biosystems	000000000003801698	FDA UDI	Class I	Active
Leica Biosystems	000000000038441307	FDA UDI	Class I	Active
CytoVision GSL 120 Robotics Upgrade for Karyotyping	23GSL120KXXROB	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision Karyotyping Station w/Dual Jai MV4Cams	23CAP001KXX2M4	FDA UDI	Class II	Unknown
Leica Biosystems	000000000003801340	FDA UDI	Class I	Active
Leica Biosystems CytoVision DM2500 for FISH	23MIC250FXX002	FDA UDI	Class II	Unknown
Leica Biosystems Ariol MSCOPE Leica DM6000B BZ03 Ariol Multibay	23MIC6004	FDA UDI	Class II	Active
Leica Biosystems CytoVision HD Image, Dell 5810 Basic, Win 7 Ultimate	23DKI5800	FDA UDI	Class II	Unknown
Leica Biosystems	000000000003801450	FDA UDI	Class I	Active
Leica Biosystems CytoVision Station Upgrade use existing Dual Jai A10	23CUP008CVXA10	FDA UDI	Class II	Unknown
Leica Biosystems	38440300	FDA UDI	Class I	Active
Leica Biosystems CytoVision MB8 scanning system for Karyotyping&FISH	23MBX008KFX001	FDA UDI	Class II	Unknown
Leica Biosystems	3800206AE	FDA UDI	Class I	Active
Leica Biosystems	000000000003801654	FDA UDI	Class I	Active
Leica biosystems HIGH TRANSM. DAPI FOR LEICA DM	232FLAL463772	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision OBJ HC PL APO 40X Oil	23OBJ040PAPOIL	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision Replace CW4000 with CV Capture+Jai M4	23CW4000UP001	FDA UDI	Class II	Unknown
Leica Biosystems	000000000003801520	FDA UDI	Class I	Active
Leica Biosystems	39LC-705-5	FDA UDI	Class I	Active
Leica Biosystems CytoVision Brightfield ChromaScan upgrade	23MBX008KXXUPG	FDA UDI	Class II	Unknown
Leica Biosystems	39LC-610-9-L	FDA UDI	Class I	Active
Leica Biosystems CytoVision CGH Software License Activation Code	23SWR000CGX001	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision CytoLink Development System	23REV009KFXCL1	FDA UDI	Class II	Unknown
Leica Biosystems	3803025	FDA UDI	Class I	Active
Leica Biosystems	3800084E	FDA UDI	Class I	Active
Leica Biosystems	3800085CL	FDA UDI	Class I	Active
Leica Biosystems	000000000038440602	FDA UDI	Class I	Active
Leica Slotted Opto Sensor	23EL000392	FDA UDI	Class II	Unknown
Leica Biosystems	39LC-550-2-L	FDA UDI	Class I	Active
Leica Biosystems	000000000003803100	FDA UDI	Class I	Active
Leica Biosystems	3800204E	FDA UDI	Class I	Active
Leica Biosystems	000000000003801500	FDA UDI	Class I	Active
Leica Biosystems	38441502	FDA UDI	Class I	Active
Leica Biosystems	000000000003800389	FDA UDI	Class I	Active
Leica Biosystems	38440502	FDA UDI	Class I	Active
Leica Biosystems	000000000038440209	FDA UDI	Class I	Active
Leica Biosystems	000000000003803815	FDA UDI	Class I	Active
Leica Biosystems	3800449CL	FDA UDI	Class I	Active
Leica Biosystems	3801000	FDA UDI	Class I	Active

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FDA Recalls (10)

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
Jul 14, 2017	Z-3125-2017	—	terminated	A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
Jul 14, 2017	Z-3124-2017	—	terminated	A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
Jul 14, 2017	Z-3122-2017	—	terminated	A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
Jul 14, 2017	Z-3120-2017	—	terminated	A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
Jul 14, 2017	Z-3123-2017	—	terminated	A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
Jul 14, 2017	Z-3121-2017	—	terminated	A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
Jul 14, 2017	Z-3126-2017	—	terminated	A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
May 6, 2016	Z-1948-2016	—	terminated	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 each manufactured system.
May 2, 2016	Z-2039-2016	—	terminated	Systems have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated with each manufactured system. The system appears to be unlicensed. These systems cannot be re-activated using standard Windows licensing procedures and are requiring checks of each potentially affected system to confirm Windows 7 OS is properly activated.
Feb 20, 2012	Z-1331-2012	—	terminated	Product was distributed with the incorrect lot number and expiration date. The lot number and expiration date should have been listed at 073013 and instead was noted as 073014 which is beyond the maximum expiration dating of 18 months for this product.