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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 9 of 12

Device	Model / Reference	Registries	Class	Status
Leica Biosystems	39LC-700-5	FDA UDI	Class I	Active
Leica Biosystems Back-UPS Pro 1300VA 110V	23UPS0004	FDA UDI	Class II	Unknown
Leica Biosystems	000000000003800330	FDA UDI	Class I	Active
Leica Biosystems	38440102	FDA UDI	Class I	Active
Leica Biosystems CytoVision Station Upgrade including new Jai M4 Camera	23CUP001CVX720	FDA UDI	Class II	Unknown
Leica Biosystems	38440009	FDA UDI	Class I	Active
Leica Biosystems	39LC-625-8-L	FDA UDI	Class I	Active
Leica Biosystems	3801090	FDA UDI	Class I	Active
Leica Biosystems	000000000003800017	FDA UDI	Class I	Active
Leica Biosystems	38441128	FDA UDI	Class I	Active
Leica Biosystems	38440401	FDA UDI	Class I	Active
Leica Biosystems	3800160G	FDA UDI	Class I	Active
Leica Biosystems	39V5001	FDA UDI	Class I	Active
Leica Biosystems	3800081CL	FDA UDI	Class I	Active
Leica Biosystems	38440108	FDA UDI	Class I	Active
Leica Biosystems	39LC-580-6-L	FDA UDI	Class I	Active
Leica Biosystems	000000000039603002	FDA UDI	Class I	Active
Leica Biosystems CytoVision HD Image, Dell 5810 RAID1 Win 7 Pro	23DKI5817	FDA UDI	Class II	Unknown
Leica Biosystems Ariol DM6000B Workstation	23ADMWS	FDA UDI	Class II	Active
Leica Biosystems Ariol Slide Exporter (SCN for DIH)	23ASASE	FDA UDI	Class II	Active
Cytolink 1.0 Software DVD	23SW0001LNK	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision GSL120 BF & FISH scanning system upgrade	23GSL120KFXUG1	FDA UDI	Class II	Unknown
Leica Biosystems	3803080	FDA UDI	Class I	Active
Leica Biosystems	000000000003800381	FDA UDI	Class I	Active
Leica Biosystems	3802646T	FDA UDI	Class I	Active
Leica Biosystems	3801080	FDA UDI	Class I	Active
Leica Biosystems Ariol Barcode Roll	23ABARCODELAB	FDA UDI	Class II	Active
Leica Biosystems	000000000003800355	FDA UDI	Class I	Active
Leica Biosystems CytoVision GSL10 scanning system for FISH	23GSL10XFXX001	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision MFISH Software License	23SWR000MFX001	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision DM2500 for Brightfield & FL	23MIC250KFX002	FDA UDI	Class II	Unknown
Leica Biosystems	000000000039602012	FDA UDI	Class I	Active
Leica Biosystems CytoVision DM2500 B CytoVision Basic Configuration	23MIC1202	FDA UDI	Class II	Unknown
Leica Biosystems	39LC-500-9-L	FDA UDI	Class I	Active
Leica Biosystems	3801087	FDA UDI	Class I	Active
Leica Biosystems CytoVision DM6000 B CytoVision Basic w/o LH	23MIC1216	FDA UDI	Class II	Unknown
Leica Biosystems	38440603	FDA UDI	Class I	Active
Leica Biosystems	3802737	FDA UDI	Class I	Active
Leica Biosystems	3800120G	FDA UDI	Class I	Active
Leica Biosystems	38440402	FDA UDI	Class I	Active
Leica Biosystems	000000000003800014	FDA UDI	Class I	Active
Leica Biosystems	3800140ACS	FDA UDI	Class I	Active
Leica Biosystems	39V4001	FDA UDI	Class I	Active
Leica Biosystems	3801480	FDA UDI	Class I	Active
Leica Biosystems CytoVision GSL10 scanning systems for Karyotyping	23GSL10XKXX001	FDA UDI	Class II	Unknown
Leica Biosystems	3802733	FDA UDI	Class I	Active
Leica Biosystems CytoVision Remote User (Karyotype & FISH)	23SWRRMTKFX001	FDA UDI	Class II	Unknown
Leica Biosystems Ariol Workstation PC for Legacy Harware	23AUWS	FDA UDI	Class II	Active
Leica Biosystems	39LC-605-5-L	EUDAMEDFDA UDI	Class I	Active
Leica Biosystems HIGH TRANSM. DUAL O/G FOR LEICA DM	232FLAL325272	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.