Clinisys CoPathPlus

GUDID B236CPP8030

The intended use of Clinisys CoPathPlus is to support anatomic pathology laboratories in the management of laboratory workflow (order entry through reporting), provide business analytics, and to transfer, store, and display test results and information. This product is intended for use by trained health care and laboratory professionals.

CliniSys, Inc

Pathology information system application software

• Primary Device ID: B236CPP8030
• NIH Device Record Key: 7dda158f-2e36-4223-9640-c9e66949d27a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clinisys CoPathPlus
• Version Model Number: 8.0.3
• 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	B236CPP8030 [Primary]

FDA Product Code

• NVV: Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System

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: 2026-02-26
• Device Publish Date: 2026-02-18

Devices Manufactured by CliniSys, Inc

• B236CPP8030 - Clinisys CoPathPlus: 2026-02-26The intended use of Clinisys CoPathPlus is to support anatomic pathology laboratories in the management of laboratory workflow (order entry through reporting), provide business analytics, and to transfer, store, and display test results and information. This product is intended for use by trained health care and laboratory professionals.
• B236CPP8030 - Clinisys CoPathPlus: 2026-02-26 The intended use of Clinisys CoPathPlus is to support anatomic pathology laboratories in the management of laboratory workflow (
• B236SQBB202420 - Clinisys SQ Blood Bank: 2026-02-02 Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: â€
• B236SQLAB202420 - Clinisys SQ Lab: 2026-02-02 Clinisys SQ Lab is intended for use by professionals working in a clinical laboratory. Clinisys SQ Lab is intended for use only
• B236CATL202510 - Clinisys Atlas: 2026-01-14 Clinisys Atlas is a solution set comprised of four solutions that can be activated individually or together to meet the needs of
• B236CLS202510 - Clinisys Laboratory Solution: 2025-08-21 The Clinisys Laboratory Solution (CLS) is a laboratory information management system that is used to manage laboratory work. The
• B236CATL202350 - Clinisys Atlas: 2025-07-21 Clinisys Atlas is a solution set comprised of four solutions that can be activated individually or together to meet the needs of
• B236SQBB202410 - Clinisys SQ Blood Bank: 2024-12-16 Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: â€
• B236SQLAB202410 - Clinisys SQ Lab: 2024-12-16 Clinisys SQ Lab is intended for use by professionals working in a clinical laboratory. Clinisys SQ Lab is intended for use only