cytoQ®

Basic Information

• Brand Name: cytoQ®
• Primary DI: 04260649292075
• Version / Model: cytoQ® Gyn Filters
• Catalog Number: 968111
• Company Name: SABEU GmbH & Co. KG
• Labeler DUNS: 316894864
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2026-02-10
• Public Version: 1
• Public Version Date: 2026-02-18
• Public Version Status: New
• Public Device Record Key: 91a3f091-5313-4cba-a2fa-7ddaafb6b482

Device Description

Non-sterile, single-use in vitro diagnostic device for preparing biological samples for subsequent diagnostic or analytical procedures. It enables sample collection through filtration from liquid phase in combination with an IVD-certified processor. Designed for clinical use by professionals. cytoQ® Gyn Filters (Pink) are recommended for processing gynecological cell samples (PAP test).

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
65389	Fluid specimen concentration filter IVD	A screening receptacle intended to concentrate a fluid clinical specimen [e.g., serum, urine, cerebrospinal fluid (CSF)] by filtration prior to in vitro diagnostic investigation. It is in the form of a container (e.g., tube, multi-well reservoir) with a semi-permeable filtering membrane, whereby specimen suspension particles [e.g., tissue culture extracts, cells, antigens, antibodies, proteins, hormones, DNA, RNA, column eluates, salts] are retained in a recoverable sub-volume of the specimen after filtration (e.g., by centrifugation, or absorption). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	04260649292068	GS1
Primary	04260649292075	GS1
Previous	04260649291368	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 4 – 30 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Store in a dry place, protected from light and UV radiation