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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 4 of 12

Device	Model / Reference	Registries	Class	Status
Leica Biosystems	3800204AE	FDA UDI	Class I	Active
Leica Biosystems	39LC-500-7-L	FDA UDI	Class I	Active
Leica Biosystems	3800150G	FDA UDI	Class I	Active
Leica Biosystems Ariol IHC Module	23ASWIHC	FDA UDI	Class II	Active
Leica Biosystems	38440503	FDA UDI	Class I	Active
Leica Biosystems	3800160ACS	FDA UDI	Class I	Active
Leica Biosystems CytoVision Auto Fish Capture System	23CAP007FXX001	FDA UDI	Class II	Unknown
Leica Biosystems	000000000038441300	FDA UDI	Class I	Active
Leica Biosystems	39LC-675-9-500	FDA UDI	Class I	Active
Leica Biosystems Adaptec 8405E Raid Controller	23BDI0036	FDA UDI	Class II	Unknown
Leica Biosystems	3800082CL	FDA UDI	Class I	Active
Leica Biosystems CytoVision OBJ HC PL APO 100X Oil	23OBJ100PAPOIL	FDA UDI	Class II	Unknown
Leica Biosystems	000000000039601006	FDA UDI	Class I	Active
ThermoBrite	3800-004852-002	FDA UDI	Class I	Active
Leica Biosystems CytoVision Karyotyping Review Station	23REV000KXX001	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision Station Upgrade existing Dual Jai CVM4	23CUP005CVMV4	FDA UDI	Class II	Unknown
Leica Biosystems	38441120	FDA UDI	Class I	Active
Leica Biosystems	000000000003802915	FDA UDI	Class I	Active
Leica Biosystems CytoVision OBJ HC PL APO 40X	23OBJ040PAPDRY	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision MB8 scanning system for Karyotyping	23MBX008KXX001	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision 7.5 Warranty upgrade DVD	23SWRWAR750	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision Karyotyping Software Update	23SWR002KLX001	FDA UDI	Class II	Unknown
Leica Biosystems	39LC-550-1-L	FDA UDI	Class I	Active
Leica Biosystems	000000000038441301	FDA UDI	Class I	Active
Leica Biosystems CytoVision Karyotyping and FISH Upgrade	23SWR001KFL001	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision Subsystem: Controller/Stage/Filterwheel	23MCS0006	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision DM6000B for FISH	23MIC600FXX002	FDA UDI	Class II	Unknown
Leica Biosystems	000000000038440210	FDA UDI	Class I	Active
Leica Biosystems	38441130	FDA UDI	Class I	Active
Leica Biosystems	38441127	FDA UDI	Class I	Active
Leica Biosystems	3802651T	FDA UDI	Class I	Active
Leica Biosystems Ariol UPS 220V	23UPS2208	FDA UDI	Class II	Active
Leica Biosystems	3803083	FDA UDI	Class I	Active
Leica Biosystems	38440110	FDA UDI	Class I	Active
Smart Ups Smc1500 1500va 120v	23UPS2215	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision HP EliteDisplay E190i LET monitor	23MON1901	FDA UDI	Class II	Unknown
Leica Biosystems	38440501	FDA UDI	Class I	Active
Leica Biosystems	000000000038441507	FDA UDI	Class I	Active
Leica Biosystems	38440109	FDA UDI	Class I	Active
Leica Biosystems CytoVision Karyotyping Station w/Jai MV4 Camera	23CAP001KXX001	FDA UDI	Class II	Unknown
CytoVision GSL 120 Robotics Upgrade for Karyo/ FISH	23GSL120KFXROB	FDA UDI	Class II	Unknown
Leica Biosystems HIGH TRANSM. GREEN FOR LEICA DM	232FLAL311572	FDA UDI	Class II	Unknown
ThermoBrite	3800-004852-003	FDA UDI	Class I	Active
Leica Biosystems CytoVision GSL10 scanning sys for Karyotyping&FISH	23GSL10XKFX001	FDA UDI	Class II	Unknown
Leica Biosystems	3800151G	FDA UDI	Class I	Active
Leica Biosystems CytoVision Prior Proscan III Filter Wheel Controller	23MIC032FWC002	FDA UDI	Class II	Unknown
Leica Biosystems	39LC-605-9-L	FDA UDI	Class I	Active
Leica Biosystems	3801091	FDA UDI	Class I	Active
Leica Biosystems	000000000039602004	FDA UDI	Class I	Active
Leica Biosystems GSL10 BF Scanning Sytem Upgrade	23GSL10XKXXUG1	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.