Sunquest Laboratory

GUDID B236LAB11000

Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunquest Laboratory is intended for use only by professionals who have received extensive training in the use of the software. Sunquest Laboratory 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

SUNQUEST INFORMATION SYSTEMS, INC.

Clinical laboratory information system application software
Primary Device IDB236LAB11000
NIH Device Record Key5cac1c50-d6da-44da-a9cb-2f03292756f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameSunquest Laboratory
Version Model Number11.0
Company DUNS052934841
Company NameSUNQUEST INFORMATION SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB236LAB11000 [Primary]

FDA Product Code

JQPCalculator/Data Processing Module, For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-01
Device Publish Date2022-06-23

On-Brand Devices [Sunquest Laboratory]

B236LAB10000Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. The s
B236LAB8230Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. The s
B236LAB8130Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. The s
B236LAB8010Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. The s
B236LAB10010Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. The s
B236LAB10100Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. The s
B236LAB10110Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. The s
B236LAB11000Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunqu

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