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cobas b 221 <6> system

FDA UDI

Class II (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name
cobas b 221 <6> system FDA UDI
Generic Name
Metabolic profile clinical chemistry analyser IVD, stationary, automated FDA UDI
Model / Reference
3337154001 FDA UDI

Identifiers

Catalog Number
3337154001 FDA UDI
Primary DI / UDI-DI
04015630018345 FDA UDI
FDA Product Code
CEM FDA UDI
GMDN Term
Metabolic profile clinical chemistry analyser IVD, stationary, automated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1600 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

Yes

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Metabolic profile clinical chemistry analyser IVD, stationary, automated

cobas b 221 <6> system by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Metabolic profile clinical chemistry analyser IVD, stationary, automated.

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 8940ff80-1317-4494-ac41-5b75c835732a 34 fields · synced May 30, 2026