X100HT System

GUDID 07290118610892

X100HT with Processing Unit and a Maintenance Kit. Includes: - X100HT Scanner - X100HT Processing Unit - X100HT User Maintenance Kit

SCOPIO LABS LTD

Cell morphology analyser IVD, automated/semi-automated

• Primary Device ID: 07290118610892
• NIH Device Record Key: 8bc1c6e3-9a26-4b72-9ea5-8a72a4360ae5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X100HT System
• Version Model Number: SC-SYS-00017
• Company DUNS: 600369986
• Company Name: SCOPIO LABS LTD
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• 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: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290118610892 [Primary]

FDA Product Code

• JOY: Device, Automated Cell-Locating

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: 2024-12-09
• Device Publish Date: 2024-12-01