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cobas&#x00AE prime Universal Tray

FDA UDI

Class I (US FDA UDI)

by Roche Molecular Systems, Inc.

Identity

Trade Name
cobas&#x00AE prime Universal Tray FDA UDI
Generic Name
Instrument/analyser specimen/reagent container carrier IVD FDA UDI
Model / Reference
08988234001 FDA UDI

Identifiers

Catalog Number
08988234001 FDA UDI
Primary DI / UDI-DI
07613336171318 FDA UDI
FDA Product Code
JQW FDA UDI
GMDN Term
Instrument/analyser specimen/reagent container carrier IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2750 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Instrument/analyser specimen/reagent container carrier IVD

cobas&#x00AE prime Universal Tray by Roche Molecular Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Instrument/analyser specimen/reagent container carrier IVD.

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 6dd57ad2-c13e-495a-abeb-a64ce8286c49 33 fields · synced Jun 9, 2026