← Back to catalogue

Clinisys SQ Lab

FDA UDI

Class I (US FDA UDI)

by CliniSys, Inc

Identity

Trade Name
Clinisys SQ Lab FDA UDI
Generic Name
Clinical laboratory information system application software FDA UDI
Device Name
Clinisys SQ Lab is intended for use by professionals working in a clinical laboratory. Clinisys SQ Lab is intended for use only by professionals who have received extensive training in the use of the software. Clinisys SQ Lab is controlled via user defined security levels, which allow the laboratories to manage data security and integrity. The system is marketed as an automated solution for managing laboratory processes, including: • Patient registration • Order entry and order modification • Specimen collection, verification, suitability, and distribution • Quality assurance checking • Workload recording • Billing charge capture • Standards and controls recording • Test order result inquiry and reporting • Organism susceptibility and epidemiology records • Microbiology culture direct examination and observation recording • Outreach clients, specimens, and results • Client-specific reporting capabilities • Inbound client service request tracking • Historical data FDA UDI
Model / Reference
11.0.3 FDA UDI
Description
Clinisys SQ Lab is intended for use by professionals working in a clinical laboratory. Clinisys SQ Lab is intended for use only by professionals who have received extensive training in the use of the software. Clinisys SQ Lab is controlled via user defined security levels, which allow the laboratories to manage data security and integrity. The system is marketed as an automated solution for managing laboratory processes, including: • Patient registration • Order entry and order modification • Specimen collection, verification, suitability, and distribution • Quality assurance checking • Workload recording • Billing charge capture • Standards and controls recording • Test order result inquiry and reporting • Organism susceptibility and epidemiology records • Microbiology culture direct examination and observation recording • Outreach clients, specimens, and results • Client-specific reporting capabilities • Inbound client service request tracking • Historical data FDA UDI

Identifiers

Primary DI / UDI-DI
B236SQLAB11030 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

Clinisys SQ Lab by CliniSys, Inc — 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

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

Manufacturer

Manufacturer
CliniSys, Inc

Sources (1)

  • FDA UDI 2de9ced5-1ccc-4f7f-a5b6-eb989220bd60 33 fields · synced May 29, 2026