FDA.reportPublic FDA data

cytoQ®

Primary DI
04260649292075
Brand
cytoQ®
Company
SABEU GmbH & Co. KG
Model
cytoQ® Gyn Filters
Catalog number
968111
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).
Published
2026-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
04260649291368PreviousGS10
04260649292075PrimaryGS10
04260649292068Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260649291368042606492913684260649291368
04260649292075042606492920754260649292075
04260649292068042606492920684260649292068

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

Contacts#

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

Regulatory Flags#

DUNS number
316894864
Device count
100
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
04260649292105cytoQ®cytoQ® Urine Filters9681132026-02-10
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
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
04260649292105cytoQ®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