← Back to catalogue

Sunquest VUE

FDA UDI

Class I (US FDA UDI)

by CliniSys, Inc

Identity

Trade Name
Sunquest VUE FDA UDI
Generic Name
Pathology information system application software FDA UDI
Device Name
The intended use of Sunquest VUE is to support laboratories in the management of patient reports and to transfer, store, and display test results and information. FDA UDI
Model / Reference
2022.1 FDA UDI
Description
The intended use of Sunquest VUE is to support laboratories in the management of patient reports and to transfer, store, and display test results and information. FDA UDI

Identifiers

Primary DI / UDI-DI
B236VUE202210 FDA UDI
FDA Product Code
NVV FDA UDI
GMDN Term
Pathology 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: Pathology information system application software

Sunquest VUE by CliniSys, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pathology information system application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
CliniSys, Inc

Sources (1)

  • FDA UDI 444e1506-1fa8-4e30-9367-c5b89b610a28 33 fields · synced May 29, 2026