Horizon

FDA UDI

Class I (US FDA UDI)

by Becton Dickinson And Company

Identity

Trade Name: Horizon FDA UDI
Generic Name: CD11b cell marker IVD, antibody FDA UDI
Device Name: BD Horizon CD11b (D12) BV605 FDA UDI
Model / Reference: 663191 FDA UDI
Description: BD Horizon CD11b (D12) BV605 FDA UDI

Identifiers

Catalog Number: 663191 FDA UDI
Primary DI / UDI-DI: 00382906631916 FDA UDI
FDA Product Code: MVU FDA UDI
GMDN Term: CD11b cell marker IVD, antibody FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.4020 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: CD11b cell marker IVD, antibody

Horizon by Becton Dickinson And Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Human CD11b (Mac-1) APC Conjugate — LIFE TECHNOLOGIES LIMITED · Class I
Human CD11b (Mac-1) Alexa Fluor® 700 Conjugate — LIFE TECHNOLOGIES LIMITED · Class I
ANTI-CD11B/ITAM — Biogenex Laboratories, Inc. · Class I
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ANTI-CD11B/ITAM — Biogenex Laboratories, Inc. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Becton Dickinson And Company

Sources (1)

FDA UDI 7faf222f-15fc-4157-bfe2-d0bb783504c9 36 fields · synced May 30, 2026