cobas z 480

FDA UDI

Class I (US FDA UDI)

by Roche Molecular Systems, Inc.

Identity

Trade Name: cobas z 480 FDA UDI
Generic Name: Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
Model / Reference: 05200881001 FDA UDI

Identifiers

Catalog Number: 05200881001 FDA UDI
Primary DI / UDI-DI: 04015630929016 FDA UDI
FDA Product Code: MKZ FDA UDI
LSL FDA UDI
MAQ FDA UDI
OOI FDA UDI
GMDN Term: Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 866.3120 FDA UDI
866.3390 FDA UDI
862.2570 FDA UDI
Commercial Distribution: Not 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

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

cobas z 480 by Roche Molecular Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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 Molecular Systems, Inc.

Sources (1)

FDA UDI 37c13be6-1f8d-4d5a-a56e-ff629700e425 34 fields · synced Jun 9, 2026