Horizon

FDA UDI

Class I (US FDA UDI)

by Becton Dickinson And Company

Identity

Trade Name: Horizon FDA UDI
Generic Name: Interferon gamma release IVD, reagent FDA UDI
Device Name: BD Horizon™ Anti-Human IgM (G20-127) BV605 FDA UDI
Model / Reference: 666661 FDA UDI
Description: BD Horizon™ Anti-Human IgM (G20-127) BV605 FDA UDI

Identifiers

Catalog Number: 666661 FDA UDI
Primary DI / UDI-DI: 00382906666611 FDA UDI
FDA Product Code: MVU FDA UDI
GMDN Term: Interferon gamma release IVD, reagent 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: Interferon gamma release IVD, reagent

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

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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 69728c24-2311-491f-82d9-6c3a46c3b002 36 fields · synced May 30, 2026