Sunquest Laboratory

GUDID B236LAB10000

Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. 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 ID: B236LAB10000
• NIH Device Record Key: 2753eaee-bba2-4a3a-9bdb-bdb995548c5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sunquest Laboratory
• Version Model Number: 10.0
• Company DUNS: 052934841
• Company Name: SUNQUEST INFORMATION SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B236LAB10000 [Primary]

FDA Product Code

• JQP: Calculator/Data Processing Module, For Clinical Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-31
• Device Publish Date: 2020-12-23

On-Brand Devices [Sunquest Laboratory]

• B236LAB10000: Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. The s
• B236LAB8230: Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. The s
• B236LAB8130: Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. The s
• B236LAB8010: Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. The s
• B236LAB10010: Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. The s
• B236LAB10100: Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. The s
• B236LAB10110: Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. The s
• B236LAB11000: Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunqu