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cobas® MRSA/SA Test

FDA UDI

Class II (US FDA UDI)

by Roche Molecular Systems, Inc.

Identity

Trade Name
cobas® MRSA/SA Test FDA UDI
Generic Name
MRSA/MSSA nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Model / Reference
1.0 FDA UDI

Identifiers

Catalog Number
06768172190 FDA UDI
Primary DI / UDI-DI
00875197004427 FDA UDI
FDA Product Code
NQX FDA UDI
OOI FDA UDI
GMDN Term
MRSA/MSSA nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.1640 FDA UDI
862.2570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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/MSSA nucleic acid IVD, kit, nucleic acid technique (NAT)

cobas® MRSA/SA Test by Roche Molecular Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as MRSA/MSSA nucleic acid IVD, kit, nucleic acid technique (NAT).

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 4709d8b5-00c8-4c11-8db7-41a6912bcf6b 33 fields · synced Jun 9, 2026