cobas&#x00AE vivoDx MRSA Control Media

FDA UDI

Class II (US FDA UDI)

by Roche Molecular Systems, Inc.

Identity

Trade Name: cobas&#x00AE vivoDx MRSA Control Media FDA UDI
Generic Name: MRSA phenotype detection IVD, kit, bioassay FDA UDI
Model / Reference: 08064768190 FDA UDI

Identifiers

Catalog Number: 08064768190 FDA UDI
Primary DI / UDI-DI: 00875197005820 FDA UDI
510(k) Number: DEN190016 FDA UDI
FDA Product Code: QIV FDA UDI
GMDN Term: MRSA phenotype detection IVD, kit, bioassay FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.1655 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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: MRSA phenotype detection IVD, kit, bioassay

cobas&#x00AE vivoDx MRSA Control Media by Roche Molecular Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as MRSA phenotype detection IVD, kit, bioassay.

cobas&#x00AE vivoDx MRSA — Roche Molecular Systems, Inc. · Class II
cobas&#x00AE vivoDx MRSA Collection and Transport Kit — Roche Molecular Systems, Inc. · Class II

Cleared under the same submission

DEN190016 also covers:

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 49ac5ffb-e2f7-4b50-94dd-55e6081af52d 34 fields · synced Jun 9, 2026