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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 1 of 2

Device	Model / Reference	Registries	Class	Status
CD11b-APC	170-081-018	FDA UDI	Class I	Active
CD3-FITC (Clone REA613)	170-081-054	FDA UDI	Class I	Active
CliniMACS CD34 Reagent	70103	FDA UDI	Unclassified	Active
Cd45-Apc	170-081-062	FDA UDI	Class I	Active
Cd21-Pe	170-081-037	FDA UDI	Class I	Active
CD3-PE (Clone BW264/56)	170-081-048	FDA UDI	Class I	Active
Cd3-Apc	170-081-006	FDA UDI	Class I	Active
7-AAD Staining Solution	170-081-088	FDA UDI	Class I	Active
Cd16-Fitc	170-081-021	FDA UDI	Class I	Active
CD66c-PE	170-081-052	FDA UDI	Class I	Active
Cd45-Pe	170-081-061	FDA UDI	Class I	Active
CD2-VioBlue	170-081-027	FDA UDI	Class I	Active
Cd25-Pe	170-081-029	FDA UDI	Class I	Active
CD42a-FITC	170-081-030	FDA UDI	Class I	Active
Cd26-Pe	170-081-023	FDA UDI	Class I	Active
CD20-VioGreen	170-081-058	FDA UDI	Class I	Active
Cd16-Pe	170-081-065	FDA UDI	Class I	Active
CD4-VioGreen (Clone VIT4)	170-081-056	FDA UDI	Class I	Active
Cd33-Apc	170-081-024	FDA UDI	Class I	Active
CD8-APC-Vio770 (Clone BW135/80)	170-081-073	FDA UDI	Class I	Active
CryoMACS® Freezing Bag 750	74403	FDA UDI	Class II	Active
CD3-VioBlue	170-081-046	FDA UDI	Class I	Active
CD22-VioBlue	170-081-041	FDA UDI	Class I	Active
Cd57-Fitc	170-081-025	FDA UDI	Class I	Active
CD38-APC (Clone REA671)	170-081-068	FDA UDI	Class I	Active
CD42b-APC	170-081-031	FDA UDI	Class I	Active
Cd27-Apc	170-081-010	FDA UDI	Class I	Active
Cd117-Pe	170-081-015	FDA UDI	Class I	Active
CD21-VioBlue	170-081-022	FDA UDI	Class I	Active
CD3-FITC (Clone BW264/56)	170-081-047	FDA UDI	Class I	Active
CD4-VioGreen (Clone REA623)	170-081-084	FDA UDI	Class I	Active
Anti-TCRa/b-PE (Clone REA652)	170-081-069	FDA UDI	Class I	Active
Anti-TCRa/b-PE (Clone BW242/412)	170-081-005	FDA UDI	Class I	Active
CD19-PE-Vio770	170-081-076	FDA UDI	Class I	Active
Cd45ra-Apc	170-081-003	FDA UDI	Class I	Active
Anti-TCRa/b-APC (Clone REA652)	170-081-070	FDA UDI	Class I	Active
Cd15-Apc	170-081-049	FDA UDI	Class I	Active
Cd14-Apc	170-081-072	FDA UDI	Class I	Active
CD62L-VioGreen	170-081-081	FDA UDI	Class I	Active
CD3-VioGreen	170-081-064	FDA UDI	Class I	Active
CryoMACS® Freezing Bag 1000	74404	FDA UDI	Class II	Active
Cd19-Apc	170-081-067	FDA UDI	Class I	Active
CD45-VioBlue (Clone 5B1)	170-081-012	FDA UDI	Class I	Active
Cd13-Pe	170-081-019	FDA UDI	Class I	Active
CD203c-PE	170-081-035	FDA UDI	Class I	Active
CD45-VioGreen (Clone 5B1)	170-081-013	FDA UDI	Class I	Active
Cd8-Fitc	170-081-008	FDA UDI	Class I	Active
Cd20-Fitc	170-081-059	FDA UDI	Class I	Active
CD300e-APC	170-081-053	FDA UDI	Class I	Active
CD4-VioBlue	170-081-007	FDA UDI	Class I	Active

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