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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 5 of 12

Device	Model / Reference	Registries	Class	Status
Leica Biosystems	000000000003801600	FDA UDI	Class I	Active
Leica Biosystems	39LC-550-3-L	FDA UDI	Class I	Active
Leica Biosystems CytoVision GSL120 BF scanning system upgrade	23GSL120KXXUG1	FDA UDI	Class II	Unknown
Leica Biosystems	39LC-550-9-L	FDA UDI	Class I	Active
Leica CAMERA, JAI CV-M2CL	23CAM0010R	FDA UDI	Class II	Unknown
Leica Biosystems	000000000038441603	FDA UDI	Class I	Active
Leica Biosystems	000000000038440203	FDA UDI	Class I	Active
Leica Biosystems	3800203AE	FDA UDI	Class I	Active
Leica Biosystems CytoVision FISH Station without Camera	23CAP001FXX201	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision GSL120 scanning system - FISH	23GSL120FXX001	FDA UDI	Class II	Active
Leica Biosystems Leica dmrb 91007 82000 CU 32mm exciters	232FL8908470	FDA UDI	Class II	Unknown
Leica Biosystems	39LC-700-4	FDA UDI	Class I	Active
Leica Biosystems	3800200E	FDA UDI	Class I	Active
Leica Biosystems Ariol Cable, stage sensor	23ASLSP030	FDA UDI	Class II	Active
Leica Biosystems Ariol Beveled Edge Slide Holder	23ASLSP016	FDA UDI	Class II	Active
Leica Biosystems	000000000038441602	FDA UDI	Class I	Active
Dell 6 BUTTON LASER MOUSE	23MOS0002	FDA UDI	Class II	Unknown
Leica Biosystems	3800206E	FDA UDI	Class I	Active
Leica Biosystems	38440000	FDA UDI	Class I	Active
Leica Biosystems Ariol SCN400 Review Station	23ASCNWS	FDA UDI	Class II	Active
Leica Biosystems	000000000038441403	FDA UDI	Class I	Active
Leica Biosystems	000000000003800387	FDA UDI	Class I	Active
Leica Biosystems CytoVision DM2500 B ERGO Head Version	23MIC1210	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision HD Image, Dell 5810 Basic Win 7 Pro	23DKI5807	FDA UDI	Class II	Unknown
Leica Biosystems	000000000038441305	FDA UDI	Class I	Active
Leica Biosystems CytoVision Manual BF & FISH Capture System	23CAP009KFX001	FDA UDI	Class II	Unknown
Leica Biosystems	3801020	FDA UDI	Class I	Active
Leica Biosystems Ariol Power Distribution 220V	23SCR220V	FDA UDI	Class II	Unknown
Leica Biosystems	3802656T	FDA UDI	Class I	Active
Leica Biosystems	000000000003801576	FDA UDI	Class I	Active
Leica Biosystems	000000000003800015	FDA UDI	Class I	Active
Leica Biosystems	000000000038441504	FDA UDI	Class I	Active
Leica Biosystems	3801658	FDA UDI	Class I	Active
Leica Biosystems Lamp Housing 106, 12V 100W, 2 Lens, 0, 55	23MIC4058	FDA UDI	Class II	Unknown
Leica Biosystems	3800150ACS	FDA UDI	Class I	Active
Leica Biosystems	39LC-705-3	FDA UDI	Class I	Active
Leica Biosystems	000000000003801360	FDA UDI	Class I	Active
Leica CytoVision GSL 120 w/o scope with DM base plate	23GSL120KXX022	FDA UDI	Class II	Unknown
Leica Biosystems	000000000003800359	FDA UDI	Class I	Active
Leica Biosystems CytoVision OBJ HC PL APO 10X	23OBJ010PAPDRY	FDA UDI	Class II	Unknown
Leica Biosystems CytoNet Single License	23SWRCTNKFX001	FDA UDI	Class II	Unknown
Leica Biosystems	38VSP58166	FDA UDI	Class I	Active
Leica Biosystems	3800200AE	FDA UDI	Class I	Active
Leica Biosystems	3800106G	FDA UDI	Class I	Active
Leica Biosystems	38440403	FDA UDI	Class I	Active
Leica Biosystems CytoVision GSL120 Slide Loader Assembly	23GSLX120	FDA UDI	Class II	Unknown
Leica Biosystems	000000000003800320	FDA UDI	Class I	Active
Leica Biosystems	39LC-610-2-L	FDA UDI	Class I	Active
Leica Biosystems	000000000003800208	FDA UDI	Class I	Active
Leica Biosystems	3800131G	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.