Is this your brand? Sign in to claim ownership.

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 8 of 12

Device	Model / Reference	Registries	Class	Status
Leica Biosystems	000000000038441509	FDA UDI	Class I	Active
Leica Biosystems	38440303	FDA UDI	Class I	Active
Leica Biosystems	000000000003800019	FDA UDI	Class I	Active
Leica Biosystems CytoVision GSL120 scanning system Karyotyping & FISH	23GSL120KFX001	FDA UDI	Class II	Unknown
Leica Biosystems	000000000038440201	FDA UDI	Class I	Active
Leica Biosystems CytoVision Z-stack software license	23SWR000ZSX001	FDA UDI	Class II	Active
Leica Biosystems	39LC-610-4-L	FDA UDI	Class I	Active
Leica Biosystems	000000000003803598	FDA UDI	Class I	Active
PC Graphics Card - Nvidia Geforce GT610	23BDG0033	FDA UDI	Class II	Unknown
Leica Biosystems	3802735	FDA UDI	Class I	Active
Leica Biosystems	3800080CL	FDA UDI	Class I	Active
Leica Biosystems	3800202AE	FDA UDI	Class I	Active
Leica Biosystems	38440305	FDA UDI	Class I	Active
Leica Biosystems	38440301	FDA UDI	Class I	Active
Leica Biosystems	3808105GEP	FDA UDI	Class I	Active
Leica Biosystems	39LC-675-8-500	FDA UDI	Class I	Active
Dell Precision 5820	23CPU1066	FDA UDI	Class II	Unknown
Leica Biosystems	3803090	FDA UDI	Class I	Active
Leica Biosystems	38440101	FDA UDI	Class I	Active
Leica Biosystems	3808100GEP	FDA UDI	Class I	Active
Leica Biosystems	38440604	FDA UDI	Class I	Active
Leica Biosystems	39LC-580-5-L	FDA UDI	Class I	Active
Leica Biosystems	38440100	FDA UDI	Class I	Active
Leica Biosystems	39LC-580-3-L	FDA UDI	Class I	Active
Leica Biosystems	38440505	FDA UDI	Class I	Active
Leica Biosystems CytoVision Update to CytoVision current version	23SWR000CVX999	FDA UDI	Class II	Unknown
Leica Biosystems	38441501	FDA UDI	Class I	Active
Gsl Oiler	23GSL0015R	FDA UDI	Class II	Unknown
Leica Biosystems	39LC-705-4	FDA UDI	Class I	Active
Leica ADAPTOR C14 TO C7, POWER SUPPLY	23ADP0002	FDA UDI	Class II	Active
Leica Biosystems CytoVision OBJ HC PL FL 63X Oil	23OBJ063PLFOIL	FDA UDI	Class II	Unknown
Leica Biosystems	39LC-580-2-L	FDA UDI	Class I	Active
Leica Biosystems CytoVision CytoLink Data Service Module	23SVRCYTOLINK	FDA UDI	Class II	Unknown
Leica Biosystems	3801657	FDA UDI	Class I	Active
Leica Biosystems Ariol Review Software	23ASWREV001	FDA UDI	Class II	Active
Leica Biosystems CytoVision Microscope Leica DM6000B for GSL	23MIC6000	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision DM2500 for Brightfield	23MIC250KXX002	FDA UDI	Class II	Unknown
Leica Biosystems	3803590	FDA UDI	Class I	Active
Leica Biosystems	39LC-625-7-L	FDA UDI	Class I	Active
Leica Biosystems CytoVision Station upgrade use existing Jai M4	23CUP003CVX720	FDA UDI	Class II	Unknown
Leica Biosystems Ariol Fluorescent Unit	23AXCITEDM	FDA UDI	Class II	Active
Leica Biosystems	39LC-625-1-L	FDA UDI	Class I	Active
Leica Biosystems	3802631T	FDA UDI	Class I	Active
Leica Biosystems CytoVision Flexible Karyotyper License Activation	23SWR000FKX001	FDA UDI	Class II	Unknown
Leica Biosystems	38441124	FDA UDI	Class I	Active
Leica Biosystems	38440105	FDA UDI	Class I	Active
Leica Biosystems	39LC-550-7-L	FDA UDI	Class I	Active
Leica Biosystems CytoVision GSL10 to GSL120 Stacker Upgrade	23GSL010UPG120	FDA UDI	Class II	Unknown
Leica Biosystems	3808102GEP	FDA UDI	Class I	Active
Dell Precision 3620	23CPU1065	FDA UDI	Class II	Unknown

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.