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Miltenyi Biotec B.V. & Co. KG

Last updated May 24, 2026

What Miltenyi Biotec B.V. & Co. KG makes

Miltenyi Biotec produces assay development reagents for in vitro diagnostics, including analyte-specific conjugates like CD11b-APC, CD3-FITC, and CD45-APC, as well as staining solutions such as 7-AAD. The company also manufactures magnetic cell separation systems, including processing units, reagent kits (e.g., CliniMACS CD34 Reagent), tubing sets, and buffered saline solutions for cell isolation and purification. Additional products include blood and tissue storage containers designed for laboratory use.

The company’s devices are classified under FDA’s Unclassified, Class I, and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Miltenyi Biotec operates primarily from the United States, adhering to regulatory requirements for in vitro diagnostics and medical devices in that jurisdiction.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: —
Website: miltenyi.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 800-367-6227
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 342920388

Catalogue (98)

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
Cd2-Fitc	170-081-028	FDA UDI	Class I	Active
CD27-VioBlue	170-081-051	FDA UDI	Class I	Active
CD25-APC (Clone REA570)	170-081-060	FDA UDI	Class I	Active
Cd33-Pe	170-081-001	FDA UDI	Class I	Active
CliniMACS Tubing Set TS	73105	FDA UDI	Unclassified	Active
Cd185-Apc	170-081-004	FDA UDI	Class I	Active
CD3-PE (Clone REA613)	170-081-055	FDA UDI	Class I	Active
CryoMACS® Freezing Bag 50	74400	FDA UDI	Class II	Active
Cd10-Apc	170-081-017	FDA UDI	Class I	Active
Anti-TCRg/d-PE-Vio770	170-081-085	FDA UDI	Class I	Active
CD20-VioBlue	170-081-009	FDA UDI	Class I	Active
Cd22-Apc	170-081-043	FDA UDI	Class I	Active
Cd62l-Fitc	170-081-026	FDA UDI	Class I	Active
Cd94-Apc	170-081-033	FDA UDI	Class I	Active
Cd45-Fitc	170-081-063	FDA UDI	Class I	Active
Cd197-Pe	170-081-034	FDA UDI	Class I	Active
Cd4-Fitc	170-081-036	FDA UDI	Class I	Active
Cd117-Apc	170-081-016	FDA UDI	Class I	Active
Cd44-Fitc	170-081-032	FDA UDI	Class I	Active
Cd27-Fitc	170-081-011	FDA UDI	Class I	Active
Cd10-Pe	170-081-000	FDA UDI	Class I	Active
Cd56-Apc	170-081-044	FDA UDI	Class I	Active
Anti-TCRa/b-APC (Clone BW242/412)	170-081-042	FDA UDI	Class I	Active
CD34-VioBlue	170-081-079	FDA UDI	Class I	Active
CryoMACS® Freezing Bag 500	74402	EUDAMEDFDA UDI	Class II	Active
Cd16-Apc	170-081-045	FDA UDI	Class I	Active
CD45-VioBlue (Clone REA747)	170-081-077	FDA UDI	Class I	Active
Cd38-Fitc	170-081-002	FDA UDI	Class I	Active
CD45-VioGreen (Clone REA747)	170-081-078	FDA UDI	Class I	Active
CliniMACS Tubing Set LS	73205	EUDAMEDFDA UDI	Unclassified	Active
Cd123-Pe	170-081-039	FDA UDI	Class I	Active
Cd56-Pe	170-081-014	FDA UDI	Class I	Active
CD197-VioBlue	170-081-083	FDA UDI	Class I	Active
CryoMACS® Freezing Bag 250	74401	EUDAMEDFDA UDI	Class II	Active
CD45RA-VioBlue	170-081-080	FDA UDI	Class I	Active
CliniMACS Plus Instrument	75101	FDA UDI	Unclassified	Active
CD19-PE (Clone LT19)	170-081-057	FDA UDI	Class I	Active
Cd15-Fitc	170-081-020	FDA UDI	Class I	Active
CD25-APC (Clone 4E3)	170-081-050	FDA UDI	Class I	Active
CD19-PE (Clone REA675)	170-081-066	FDA UDI	Class I	Active
Anti-TCRg/d-PE	170-081-071	FDA UDI	Class I	Active
CD38-APC (Clone IB6)	170-081-038	FDA UDI	Class I	Active
CD19-VioBlue	170-081-040	FDA UDI	Class I	Active
CD8-APC-Vio770 (Clone REA734)	170-081-075	FDA UDI	Class I	Active
CD20-PE-Vio770	170-081-074	FDA UDI	Class I	Active
CliniMACS PBS/EDTA Buffer 1L	70026	FDA UDI	Unclassified	Active
Cd45ra-Fitc	170-081-086	FDA UDI	Class I	Active
CD62L-PE-Vio770	170-081-082	FDA UDI	Class I	Active

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FDA Establishments (1)

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Miltenyi Biotec B. V. & Co. KG Bergisch Gladbach North Rhine-Westphalia · DE FEI 3004112148