Clinisys SQ Lab

GUDID B236SQLAB11030

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

CliniSys, Inc

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• Primary Device ID: B236SQLAB11030
• NIH Device Record Key: 2de9ced5-1ccc-4f7f-a5b6-eb989220bd60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clinisys SQ Lab
• Version Model Number: 11.0.3
• Company DUNS: 052934841
• Company Name: CliniSys, 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	B236SQLAB11030 [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: 2024-03-18
• Device Publish Date: 2024-03-10

Devices Manufactured by CliniSys, Inc

• B236CATL202330 - Clinisys Atlas: 2024-05-10 Clinisys Atlas is a solution set comprised of four solutions that can be activated individually or together to meet the needs of
• B236CLS2023200 - Clinisys Laboratory Solutions: 2024-05-10 The Clinisys Laboratory Solutions (CLS) is a laboratory information management system that is used to manage laboratory work. Th
• B236CLS20232140 - Clinisys Laboratory Solutions: 2024-03-26 The Clinisys Laboratory Solutions (CLS) is a laboratory information management system that is used to manage laboratory work. Th
• B236SQBB11030 - Clinisys SQ Blood Bank: 2024-03-18 Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: �
• B236SQLAB11030 - Clinisys SQ Lab: 2024-03-18Clinisys 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
• B236SQLAB11030 - Clinisys SQ Lab: 2024-03-18 Clinisys SQ Lab is intended for use by professionals working in a clinical laboratory. Clinisys SQ Lab is intended for use only
• B236CATL202320 - Clinisys Atlas: 2023-12-11 Clinisys Atlas is a solution set comprised of four solutions that can be activated individually or together to meet the needs of
• B236ATL2022110 - Sunquest Atlas: 2023-07-31 Sunquest Atlas is a solution set comprised of four solutions that can be activated individually or together to meet the needs of
• B236CLS202310 - Clinisys Laboratory Solutions: 2023-07-14 The Clinisys Laboratory Solutions (CLS) is a laboratory information management system that is used to manage laboratory work. Th