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cobas infinity POC

FDA UDI

Class I (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name
cobas infinity POC FDA UDI
Generic Name
Clinical laboratory information system application software FDA UDI
Model / Reference
09159053001 FDA UDI

Identifiers

Catalog Number
09159053001 FDA UDI
Primary DI / UDI-DI
07613336175385 FDA UDI
FDA Product Code
JQP FDA UDI
GMDN Term
Clinical laboratory information system application software FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2100 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Clinical laboratory information system application software

cobas infinity POC by Roche Diagnostics Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Clinical laboratory information system application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Roche Diagnostics Corp.

Sources (1)

  • FDA UDI 22707d79-0d72-4936-b522-3ce303ad01a4 33 fields · synced May 30, 2026