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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 10 of 12

Device	Model / Reference	Registries	Class	Status
Leica Biosystems CytoVision Subsystem: Microscope, Leica DM6000B Multi	23MIC6002	FDA UDI	Class II	Unknown
Leica Biosystems	000000000003803591	FDA UDI	Class I	Active
Leica Biosystems CytoVision Karyotyping & FISH Review station	23REV000KFX001	FDA UDI	Class II	Unknown
Leica Biosystems	39LC-610-1-L	FDA UDI	Class I	Active
Leica Biosystems	000000000038441303	FDA UDI	Class I	Active
Leica Biosystems	39LC-700-2	FDA UDI	Class I	Active
Leica Biosystems CytoVision Capture station upgrade use existing DFC	23CUP004CVX710	FDA UDI	Class II	Unknown
ThermoBrite	3800-004852-001	FDA UDI	Class I	Active
Leica Biosystems	000000000003800340	FDA UDI	Class I	Active
Leica Biosystems	000000000003801606	FDA UDI	Class I	Active
Leica Biosystems	38440004	FDA UDI	Class I	Active
Leica Biosystems CytoVision OBJ HC PL FL 40X	23OBJ040PLFDRY	FDA UDI	Class II	Unknown
Leica Biosystems Ariol Batch Processing Module	23ASWBATCH	FDA UDI	Class II	Active
Leica Biosystems	38440003	FDA UDI	Class I	Active
Leica Biosystems	38440500	FDA UDI	Class I	Active
Leica Biosystems	000000000038441600	FDA UDI	Class I	Active
Leica Biosystems CytoVision OBJ HC PL APO 63X OIL CORR TIRF	23OBJ063PAPOIL02	FDA UDI	Class II	Unknown
CytoVision V7.6 configuration	23SWR00076CV	FDA UDI	Class II	Unknown
Leica Biosystems	3800152	FDA UDI	Class I	Active
Leica Biosystems CytoVision X-Cite Basic Unit	23LMP0008	FDA UDI	Class II	Unknown
Leica Biosystems	3800145G	FDA UDI	Class I	Active
Leica Biosystems	000000000038441306	FDA UDI	Class I	Active
Leica Biosystems	3800061CL	FDA UDI	Class I	Active
Leica Biosystems CytoVision DM5500B for Brightfield	23MIC550KXX002	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision FISH Software Update	23SWR002FLX001	FDA UDI	Class II	Unknown
Leica Biosystems	3802739	FDA UDI	Class I	Active
Leica Biosystems	3800147G	FDA UDI	Class I	Active
Leica Biosystems	3803045	FDA UDI	Class I	Active
Leica Biosystems	39LC-605-4-L	FDA UDI	Class I	Active
Leica Biosystems	3801481	FDA UDI	Class I	Active
Leica Biosystems	39LC-500-1-L	EUDAMEDFDA UDI	Class I	Active
Leica Biosystems HIGH TRANSM. ORANGE FOR LEICA DM	232FLAL311972	FDA UDI	Class II	Unknown
Leica Biosystems Ariol DM6000 B for Ariol PL200 Refurbished	23MIC1206R	FDA UDI	Class II	Active
Leica Biosystems Ariol General Analysis Module	23ASWGM	FDA UDI	Class II	Active
Leica Biosystems	3800083CL	FDA UDI	Class I	Active
Leica Biosystems	3800003	FDA UDI	Class I	Active
Leica Biosystems	3800080E	FDA UDI	Class I	Active
Leica Biosystems	3800073	FDA UDI	Class I	Active
Leica Biosystems GSL120 Stacker	23GSL6016R	FDA UDI	Class II	Unknown
Leica Biosystems	38440104	FDA UDI	Class I	Active
Leica Biosystems	39LC-675-3-500	FDA UDI	Class I	Active
Leica Biosystems	000000000003800386	FDA UDI	Class I	Active
Leica Biosystems CytoVision OBJ HC PL FL 20X	23OBJ020PLFDRY	FDA UDI	Class II	Unknown
Leica Biosystems	3800201E	FDA UDI	Class I	Active
Leica Biosystems	000000000039601095	FDA UDI	Class I	Active
Leica Biosystems CytoVision Station Upgrade iwht Dual Jai CVM4	23CUP001CVMV4	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision DM5500B for FISH	23MIC550FXX002	FDA UDI	Class II	Unknown
Leica Biosystems	000000000003801571	EUDAMEDFDA UDI	Class I	Active
Leica Bisosystems	000000000038441308	FDA UDI	Class I	Active
Back Ups 1400va 230v	23UPS0007	FDA UDI	Class II	Unknown

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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.