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tetraONE software

FDA UDI

Class II (US FDA UDI)

by Beckman Coulter, Inc.

Identity

Trade Name
tetraONE software FDA UDI
Generic Name
Laboratory instrument/analyser application software IVD FDA UDI
Device Name
tetraONE FDA UDI
Model / Reference
6915050 FDA UDI
Description
tetraONE FDA UDI

Identifiers

Catalog Number
6915050 FDA UDI
Primary DI / UDI-DI
15099590572679 FDA UDI
FDA Product Code
GKZ FDA UDI
GMDN Term
Laboratory instrument/analyser application software IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.5220 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Laboratory instrument/analyser application software IVD

tetraONE software by Beckman Coulter, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laboratory instrument/analyser application software IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Beckman Coulter, Inc.

Sources (1)

  • FDA UDI 06b6ae6e-613f-4bc8-b156-73c83695b960 34 fields · synced Jun 8, 2026