Manufacturer

Bdbiosciences

United StatesLegal entities : Becton, Dickinson and Company, BD Biosciences

Markets : Belgium · United States

Approvals : EU – class A, B, C · United States (FDA) – 510(k) : 11 · class II · latest in 2026 · see on the FDA website

EU representative : Becton Dickinson Ireland Limited (Ireland)

Website EUDAMEDenquiries@bd.com

16 categories, 83 models including 83 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Antibodies for b and t-cell subtyping	W0103080101	BD MULTITEST BD MULTITEST BD TRUCOUNT BD MULTITEST BD TRUCOUNT BD Multitest™ CD3/CD16+CD56/CD45/CD19 with BD Trucount™ Tubes BD MULTITEST BD TRUCOUNT BD Multitest™ CD3/CD8/CD45/CD4 with BD Trucount™ Tubes BD Multitest™ 6-Color TBNK 35 others BD Multitest™ 6-Color TBNK with BD Trucount™ Tubes BD Multitest™ CD3/CD16+CD56/CD45/CD19 BD ONEFLOW3 refs BD TRITEST BD TRUCOUNT "BD Tritest™ CD3/CD4/CD45 with BD Trucount™ Tubes" BD TRITEST BD TRUCOUNT BD Tritest™ CD4/CD8/CD3 with BD Trucount™ Tubes BD Tritest™ CD3/CD4/CD45 Horizon CD138 Single Color Reagents3 refs Horizon CD27 Single Color Reagents3 refs Horizon CD279 Single Color Reagent Horizon CD3 Single Color Reagents3 refs Horizon CD45RA Single Color Reagents3 refs Horizon CD81 Single Color Reagent Not Applicable3 refs Not Applicable Anti-TCR-α/β (WT31) single color reagent Not Applicable Anti-TCR-γ/δ (11F2) single color reagent Not Applicable BD® Anti-Kappa (TB 28-2)3 refs Not Applicable BD® CD10 (HI10a)3 refs Not Applicable BD® CD193 refs Not Applicable BD® CD20 (L27)3 refs Not Applicable BD® CD22 (S-HCL-1)3 refs Not Applicable BD® CD23 (EBVCS-5)2 refs Not Applicable BD® CD45 (2D1)3 refs Not Applicable BD® CD79b (SN8)3 refs Not Applicable BD® FMC7 Not Applicable CD152 Single Color Reagent Not Applicable CD1a Single Color Reagent Not Applicable CD2 Single Color Reagents3 refs Not Applicable CD25 Single Color Reagents3 refs Not Applicable CD34 Single Color Reagents3 refs Not Applicable CD4 Single Color Reagents3 refs Not Applicable CD5 Single Color Reagents3 refs Not Applicable CD56 Single Color Reagents3 refs Not Applicable CD57 Single Color Reagent Not Applicable CD79a Single Color Reagents3 refs Not Applicable CD8 Single Color Reagents3 refs	C IVDR	EUDAMED record Report an error
Monoclonal antibodies for cell surface antigens - other	W0103080199	BD HLA-B27 Kit98/79 BD MULTITEST98/79 BD Multitest CD8/CD38/CD3/HLA-DR98/79 BD Plasma Count Kit With BD Trucount Tubes98/79 Horizon CD123 Single Color Reagent 14 others Horizon CD14 Single Color Reagents3 refs Horizon CD64 Single Color Reagent Not Applicable8 refs Not Applicable CD103 Single Color Reagents2 refs Not Applicable CD117 Single Color Reagents3 refs Not Applicable CD11B Single Color Reagents3 refs Not Applicable CD11c Single Color Reagents2 refs Not Applicable CD13 Single Color Reagents3 refs Not Applicable CD15 Single Color Reagent Not Applicable CD16 Single Color Reagents3 refs Not Applicable CD33 Single Color Reagents3 refs Not Applicable CD41a Single Color Reagents2 refs Not Applicable CD61 Single Color Reagents2 refs Not Applicable CD71 Single Color Reagents2 refs	C IVDR, 98/79	EUDAMED record Report an error
Setup beads	W0103080401	BD FACSDiva CS&T IVD Beads (50 tests)2 refs BD ONEFLOW FACS 7-C Setup Bead FC Beads 8-Color Kit for BD OneFlow™ Not Applicable2 refs	A IVDR	EUDAMED record Report an error
Auxiliary & supplemental reagents for flow cytometry - other	W0103080599	BD FACSFLOW BD INTRASURE FACS Horizon	A IVDR	EUDAMED record Report an error
Antibodies for recognizing cell surface receptors	W0103080104	CYTOGNOS CD38 Single Color Reagents3 refs Not Applicable3 refs	A, C IVDR	EUDAMED record Report an error
Lymphocyte subtyping controls	W0103080403	BD MULTI-CHECK3 refs BD Multi-Check CD4 Low Controls3 refs	C IVDR	EUDAMED record Report an error
Reagents for flow cytometry - other	W0103080699	BD ONEFLOW3 refs BD ONEFLOW Oneflow B-CLPD T1	C IVDR	EUDAMED record Report an error
Autosamplers	W02069001	BD FACSDUET2 refs	A IVDR	EUDAMED record Report an error
Cell staining reagents for cell nuclear staining	W0103080501	BD LEUCOCOUNT	B IVDR	EUDAMED record Report an error
Cytoflowmeters - hardware accessories	W0202040180	FACS	A IVDR	EUDAMED record Report an error
Cytoflowmeters - high routine	W0202040103	BD FACSLYRIC3 refs	A IVDR	EUDAMED record Report an error
Flow cytometry controls - other	W0103080499	BD TRUCOUNT2 refs	C IVDR	EUDAMED record Report an error
Flow cytometry instruments - other	W02020499	FACS2 refs	A IVDR	EUDAMED record Report an error
Leucocyte controls	W0103080402	BD LEUCOCOUNT3 refs	B IVDR	EUDAMED record Report an error
Stem cell enumeration controls	W0103080404	Not Applicable	B IVDR	EUDAMED record Report an error
Stem cell enumeration reagents	W01030803	Not Applicable	B IVDR	EUDAMED record Report an error

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