X100HT with Full Field Peripheral Blood Smear (PBS) Application

Basic Information

• Brand Name: X100HT with Full Field Peripheral Blood Smear (PBS) Application
• Primary DI: 07290018417140
• Version / Model: SC-SYS-00002
• Company Name: SCOPIO LABS LTD
• Labeler DUNS: 600369986
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-30
• Public Version: 1
• Public Version Date: 2023-01-09
• Public Version Status: New
• Public Device Record Key: c541536b-a369-402a-9034-4b40b99f0f26

Device Description

X100HT with Processing Unit and FF-PBS application. Includes: - X100HT Scanner - X100HT Processing Unit - X100HT User Maintenance Kit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JOY	Device, Automated Cell-Locating	Hematology	864.5260	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61864	Cell morphology analyser IVD, automated/semi-automated	An electrically-powered automated or semi-automated laboratory instrument intended to be used to capture digital images of a clinical specimen at the microscopic level in order to view, count, record and evaluate the morphological characteristics of the cells and other biological components. It is a computerized optical unit consisting of a microscope, camera and software.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290018417140	GS1

Premarket Submissions

Submission Number	Supplement Number
K220013	000