PathTezt®

Basic Information

• Brand Name: PathTezt®
• Primary DI: 09551020410504
• Version / Model: GF-0825100
• Company Name: BIOCYTECH CORPORATION SDN. BHD.
• Labeler DUNS: 865773902
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-11
• Public Version: 1
• Public Version Date: 2026-03-19
• Public Version Status: New
• Public Device Record Key: aa07b5b8-db24-406d-846d-fe3dcd53eb87

Device Description

The filters work with an LBC processor to capture cells from PathTezt® Preserve Cell Solution and transfer them as a monolayer onto a microscope slide for cytological analysis.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KET	Filters, Cell Collection, Tissue Processing	Pathology	864.3010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
67371	Cytology specimen filter IVD	A device with a selectively permeable membrane intended to be used to isolate the cellular components of a cytology specimen suspended in a transport or culture medium, for subsequent in vitro diagnostic investigation. It is typically in the form of a mesh-like film which may be encased in plastic, designed to fit onto the opening of the cytology specimen container, to capture and collect the cells while allowing the medium to flow from the receptable through the membrane. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09551020410504	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]