B-Gate Interface

FDA UDI

Class I (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name: B-Gate Interface FDA UDI
Generic Name: Specimen processing instrument IVD FDA UDI
Model / Reference: 06884750001 FDA UDI

Identifiers

Catalog Number: 06884750001 FDA UDI
Primary DI / UDI-DI: 04015630942305 FDA UDI
FDA Product Code: JQP FDA UDI
GMDN Term: Specimen processing instrument IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.2100 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Specimen processing instrument IVD

B-Gate Interface by Roche Diagnostics Corp. — 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: Roche Diagnostics Corp.

Sources (1)

FDA UDI 66b520f7-2ea0-4096-8c81-f086cb747b9e 33 fields · synced May 30, 2026