FDA.reportPublic FDA data

PathTezt®

Primary DI
09551020410085
Brand
PathTezt®
Company
BIOCYTECH CORPORATION SDN. BHD.
Model
UCF-0813100
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 urine cell analysis.
Published
2026-03-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
09551020410085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09551020410085095510204100859551020410085

GMDN Terms#

Term, Definition table
TermDefinition
Cytology specimen filter IVDA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-887-846-5393mseidel@cancerdiagnostics.com

Regulatory Flags#

DUNS number
865773902
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09551020410009PathTezt®PTIA-20212026-03-11
09551020410016PathTezt®LBC-20092026-03-11
09551020410030PathTezt®NGPCS-200920 2026-03-11
09551020410047PathTezt®PCS-9262026-03-11
09551020410054PathTezt®CTLS-9260604 2026-03-11
09551020410078PathTezt®NGF-0525100 2026-03-11
09551020410092PathTezt®CS-361002026-03-11
09551020410108PathTezt®PCS-2009202026-03-11
09551020410115PathTezt®EV-600102026-03-11
09551020410146PathTezt®PDR-10002026-03-11
09551020410221PathTezt®PCS-200910E2026-03-11
09551020410238PathTezt®PCS-2009052026-03-11
09551020410245PathTezt®PCS-2009032026-03-11
09551020410252PathTezt®PCS-2009012026-03-11
09551020410283PathTezt®EV-600052026-03-11
09551020410313PathTezt®DF-25082026-03-11
09551020410320PathTezt®IS-361002026-03-11
09551020410337PathTezt®US-361002026-03-11
09551020410344PathTezt®HS-361002026-03-11
09551020410351PathTezt®CG-1024502026-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09551020410078PathTezt®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
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