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cobas&#x00AE vivoDx MRSA

FDA UDI

Class II (US FDA UDI)

by Roche Molecular Systems, Inc.

Identity

Trade Name
cobas&#x00AE vivoDx MRSA FDA UDI
Generic Name
MRSA phenotype detection IVD, kit, bioassay FDA UDI
Model / Reference
08380180190 FDA UDI

Identifiers

Catalog Number
08380180190 FDA UDI
Primary DI / UDI-DI
00875197006193 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: MRSA phenotype detection IVD, kit, bioassay

cobas&#x00AE vivoDx MRSA 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.

Cleared under the same submission

DEN190016 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Roche Molecular Systems, Inc.

Sources (1)

  • FDA UDI feae947e-0428-4876-b66e-0bcea2a64777 34 fields · synced Jun 9, 2026