FDA.reportPublic FDA data

cytoQ®

Primary DI
04260649292105
Brand
cytoQ®
Company
SABEU GmbH & Co. KG
Model
cytoQ® Urine Filters
Catalog number
968113
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® Urine Filters (Yellow) are recommended for processing urine cytology samples.
Published
2026-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KETFilters, Cell Collection, Tissue Processing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KETFilters, Cell Collection, Tissue ProcessingPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260649291405PreviousGS10
04260649292112PrimaryGS10
04260649292105Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260649291405042606492914054260649291405
04260649292112042606492921124260649292112
04260649292105042606492921054260649292105

GMDN Terms#

Term, Definition table
TermDefinition
Fluid specimen concentration filter IVDA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature4 Degrees Celsius30 Degrees Celsius
Special Storage Condition, Specify00Store in a dry place, protected from light and UV radiation
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+495551910100info@sabeu.com

Regulatory Flags#

DUNS number
316894864
Device count
100
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260649292075cytoQ®cytoQ® Gyn Filters9681112026-02-10
04260649292099cytoQ®cytoQ® Non-Gyn Filters9681122026-02-10
04260649292112cytoQ®cytoQ® Urine Filters9681132026-02-10
04260649292068cytoQ®cytoQ® Gyn Filters9681112026-02-10
04260649292082cytoQ®cytoQ® Non-Gyn Filters9681122026-02-10
04260649291368cellQART®cytoQART GYN (PAP) Filters9681112021-10-01
04260649291382cellQART®cytoQART NON-GYN (LBC) Filters9681122021-10-01
04260649291405cellQART®cytoQART URINE Filters9681132021-10-01
04260649291351cellQART®cytoQART GYN (PAP) Filters9681112021-10-01
04260649291375cellQART®cytoQART NON-GYN (LBC) Filters9681122021-10-01
04260649291399cellQART®cytoQART URINE Filters9681132021-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09551020410078PathTezt®BIOCYTECH CORPORATION SDN. BHD.KET2026-03-11
09551020410085PathTezt®BIOCYTECH CORPORATION SDN. BHD.KET2026-03-11
09551020410313PathTezt®BIOCYTECH CORPORATION SDN. BHD.KET2026-03-11
09551020410504PathTezt®BIOCYTECH CORPORATION SDN. BHD.KET2026-03-11
09551020410511PathTezt®BIOCYTECH CORPORATION SDN. BHD.KET2026-03-11
04260649292075cytoQ®SABEU GmbH & Co. KGKET2026-02-10
04260649292099cytoQ®SABEU GmbH & Co. KGKET2026-02-10
04260649292112cytoQ®SABEU GmbH & Co. KGKET2026-02-10
04260649292068cytoQ®SABEU GmbH & Co. KGKET2026-02-10
04260649292082cytoQ®SABEU GmbH & Co. KGKET2026-02-10
07898027900792CELLPRESERV KOLPLASTKolplast C IKET2023-11-29
00630094188508Bioseal Inc.BIOSEALKET2023-10-05
00630094188515Bioseal Inc.BIOSEALKET2023-10-05
00630094188607Bioseal Inc.BIOSEALKET2023-10-05
00630094887029Bioseal Inc.BIOSEALKET2023-10-05
00630094889054Bioseal Inc.BIOSEALKET2023-10-05
10630094188505Bioseal Inc.BIOSEALKET2023-10-05
10630094188512Bioseal Inc.BIOSEALKET2023-10-05
10630094188604Bioseal Inc.BIOSEALKET2023-10-05
10630094887026Bioseal Inc.BIOSEALKET2023-10-05
10630094889051Bioseal Inc.BIOSEALKET2023-10-05
00853778007005Double Cytology Funnel w/ White Card and CapsBiomedical Polymers, Inc.KET2023-08-21
00853778007135BMP Medical Single Cytology Funnel w/ White CardBiomedical Polymers, Inc.KET2023-08-21
00853778007142Single Cytology Funnel w/ Brown CardBiomedical Polymers, Inc.KET2023-08-21
00853778007159BMP Medical Metal Cytology ClipBiomedical Polymers, Inc.KET2023-08-21
20853778007009Double Cytology Funnel w/ White Card and CapsBiomedical Polymers, Inc.KET2023-08-21
10853778007132BMP Medical Single Cytology Funnel w/ White CardBiomedical Polymers, Inc.KET2023-08-21
10853778007149Single Cytology Funnel w/ Brown CardBiomedical Polymers, Inc.KET2023-08-21
10853778007156BMP Medical Metal Cytology ClipBiomedical Polymers, Inc.KET2023-08-21
30853778007136BMP Medical Single Cytology Funnel w/ White CardBiomedical Polymers, Inc.KET2023-08-21