Lab Composer

GUDID 03770035155057

Lab Composer is a software middleware intended for use by laboratory professionals in single-site and multi-site clinical laboratories performing in vitro diagnostic testing. The software is designed to automate the acquisition, consolidation, supervision, and transfer of data between in vitro diagnostic (IVD) instruments and Laboratory Information Systems (LIS), Lab Composer enables real-time data centralization, automated result verification, and standardized workflow orchestration across multiple laboratory disciplines, including clinical chemistry, hematology, and immunoassays. The device does not perform biological sample analysis.

BYG INFORMATIQUE

Clinical laboratory information system application software

• Primary Device ID: 03770035155057
• NIH Device Record Key: f3ffb0e9-9e5f-43ee-b384-6ace9b560e6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lab Composer
• Version Model Number: 1
• Company DUNS: 390482891
• Company Name: BYG INFORMATIQUE
• 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
GS1	03770035155057 [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: 2026-02-09
• Device Publish Date: 2026-01-30

Devices Manufactured by BYG INFORMATIQUE

• 03770035155057 - Lab Composer: 2026-02-09Lab Composer is a software middleware intended for use by laboratory professionals in single-site and multi-site clinical laboratories performing in vitro diagnostic testing. The software is designed to automate the acquisition, consolidation, supervision, and transfer of data between in vitro diagnostic (IVD) instruments and Laboratory Information Systems (LIS), Lab Composer enables real-time data centralization, automated result verification, and standardized workflow orchestration across multiple laboratory disciplines, including clinical chemistry, hematology, and immunoassays. The device does not perform biological sample analysis.
• 03770035155057 - Lab Composer: 2026-02-09 Lab Composer is a software middleware intended for use by laboratory professionals in single-site and multi-site clinical labora
• 03770035155064 - POC Controller: 2026-02-09 POC Controller is a software middleware intended for use by laboratory professionals in single-site and multi-site clinical labo
• 03770035155002 - nYna: 2025-02-10 nYna is a unique solution, both technologically and functionally, for production control and quality management within the labor
• 03770035155019 - Ypoc: 2025-02-10 Middleware dedicated to EBMD management. The proliferation of delocalised instruments, their openness to all suppliers and the n