cobas® 4800 Systems Internal Control Kit

FDA UDI

Class II (US FDA UDI)

by Roche Molecular Systems, Inc.

Identity

Trade Name: cobas® 4800 Systems Internal Control Kit FDA UDI
Generic Name: Exogenous DNA/RNA internal control IVD, kit FDA UDI
Model / Reference: 1.0 FDA UDI

Identifiers

Catalog Number: 06768318190 FDA UDI
Primary DI / UDI-DI: 00875197004458 FDA UDI
FDA Product Code: OQO FDA UDI
GMDN Term: Exogenous DNA/RNA internal control IVD, kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.3305 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Exogenous DNA/RNA internal control IVD, kit

cobas® 4800 Systems Internal Control Kit by Roche Molecular Systems, Inc. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Roche Molecular Systems, Inc.

Sources (1)

FDA UDI c1069712-74c2-49d1-a950-0c6041c2cb69 33 fields · synced Jun 9, 2026