cobas u 601 urine analyzer

FDA UDI

Class I (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name: cobas u 601 urine analyzer FDA UDI
Generic Name: Urine analyser IVD, laboratory FDA UDI
Model / Reference: 06390498001 FDA UDI

Identifiers

Catalog Number: 06390498001 FDA UDI
Primary DI / UDI-DI: 04015630932443 FDA UDI
FDA Product Code: KQO FDA UDI
GMDN Term: Urine analyser IVD, laboratory FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.2900 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Urine analyser IVD, laboratory

cobas u 601 urine analyzer 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 16c71a5c-410e-456d-b5e4-187483ff5a49 33 fields · synced Jun 8, 2026