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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 1 of 12

Device	Model / Reference	Registries	Class	Status
Prostate Kit	3800852	EUDAMED	Class A	Active
Prostate Kit	3800854	EUDAMED	Class A	Active
Prostate Kit	3800850	EUDAMED	Class A	Active
Leica Biosystems	38440504	FDA UDI	Class I	Active
Leica Biosystems	000000000038440202	FDA UDI	Class I	Active
Leica Biosystems	38440605	FDA UDI	Class I	Active
Leica Biosystems	3800220	FDA UDI	Class I	Active
Leica Biosystems	000000000003800382	FDA UDI	Class I	Active
Leica Biosystems CytoVision Karyotyping Software Upgrade	23SWR001KLX001	FDA UDI	Class II	Unknown
Leica Biosystems	000000000038440601	FDA UDI	Class I	Active
Leica Biosystems	000000000038441609	FDA UDI	Class I	Active
Leica Biosystems	39LC-625-3-L	FDA UDI	Class I	Active
Leica Biosystems CytoVision Capture Station UG use existing Jai +CV	23CUP011CVMCVR	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision Karyotyping Software License Activation	23SWR000KLX001	FDA UDI	Class II	Unknown
Leica Biosystems	000000000003800299	FDA UDI	Class I	Active
Leica Biosystems	3800240	FDA UDI	Class I	Active
Leica Biosystems	000000000003801560	FDA UDI	Class I	Active
Leica Biosystems	39LC-605-11-L	FDA UDI	Class I	Active
Leica Biosystems	3800205E	FDA UDI	Class I	Active
Leica Biosystems	3800120ACS	FDA UDI	Class I	Active
Leica Biosystems	23MOS0001	FDA UDI	Class II	Unknown
Leica Biosystems	000000000003801470	FDA UDI	Class I	Active
Leica Biosystems	3801655	FDA UDI	Class I	Active
Leica Biosystems Ariol DM6000 B Basic Configuration Ariol	23MIC1201	FDA UDI	Class II	Active
Leica Biosystems	3808104GEP	FDA UDI	Class I	Active
Leica Biosystems	38441500	FDA UDI	Class I	Active
Leica Biosystems	39LC-500-3-L	FDA UDI	Class I	Active
Leica Biosystems Ariol Camera Small, Jai CVM4	23ACM4	FDA UDI	Class II	Active
Leica Biosystems	38440106	FDA UDI	Class I	Active
Leica Biosystems	14020108926	EUDAMEDFDA UDI	Class I	Active
Leica Biosystems	000000000003800384	FDA UDI	Class I	Active
Leica Biosystems	39LC-580-11-L	FDA UDI	Class I	Active
Leica Biosystems CytoVision MB8 scanning system for FISH	23MBX008FXX001	FDA UDI	Class II	Unknown
Leica Biosystems	000000000038441310	FDA UDI	Class I	Active
Leica Biosystems	38440308	FDA UDI	Class I	Active
Leica Biosystems	000000000003801570	FDA UDI	Class I	Active
Leica Biosystems	39LC-675-7-500	FDA UDI	Class I	Active
Leica Biosystems CytoVision GSL 10 & 120 Fluorescence Upgrade	23GSLXXKUPGXKF	FDA UDI	Class II	Unknown
Leica Biosystems	39LC-705-2	FDA UDI	Class I	Active
Leica Biosystems HP Z420 Workstation R	23CPUZ420HP01R	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision DM 6000B KF for MB8 upgrade	23MIC600KFX901	FDA UDI	Class II	Unknown
Leica Biosystems CytoVision DM5500 for FL-Ergo Head	23MIC550FXX009	FDA UDI	Class II	Active
Leica Biosystems	39LC-550-8-L	FDA UDI	Class I	Active
Leica Biosystems	3800285	FDA UDI	Class I	Active
Leica Biosystems CytoVision OBJ HC PL APO 20X	23OBJ020PAPDRY	FDA UDI	Class II	Unknown
Win10cpu Upgrade For Capture(inwarranty)	23CAPWARW10CPU	FDA UDI	Class II	Unknown
Leica Biosystems	3803082	FDA UDI	Class I	Active
Leica Biosystems CytoVision CV Terminal Server User License Karyo	23SWRRMTKXX016	FDA UDI	Class II	Unknown
Leica Biosystems	39LC-605-7-L	FDA UDI	Class I	Active
Leica Biosystems	39LC-700-1	FDA UDI	Class I	Active

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Authorities

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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.