PathTezt®

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.

Registry build 21.09.26
9manufacturers in China registered for this device type
5catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (5), Guangdong (2), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KET
Manufacturer City Province Registered as Device types
HUA Cheng XIN Plastic Mold Co., Ltd. Shenzhen Guangdong Contract manufacturer 5
Guangzhou Komaspec Mechanical AND Electrical Products Manufa Huashan Town, Huadu District Guangdong Contract manufacturer 4
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Infitek Co., Ltd. Shanghai Shanghai Manufacturer 49
Citotest Labware Manufacturing Co., Ltd. Haimen Jiangsu Repacker / relabeller 46
Citotest Scientific Co., Ltd. Nanjing Jiangsu Repacker / relabeller 46
Changzhou Meiguan Care Products Technology Co., Ltd. Changzhou Jiangsu Manufacturer 32
Henan Joinkona Medical Products Stock Co., Ltd. Pingdingshan Henan Contract manufacturer 12
Jiangsu Huida Medical Instruments Co., Ltd. Yancheng Jiangsu Contract manufacturer 10

Record

Regulatory record for PathTezt®
Listed by Biocytech Corporation SDN BHD, Malaysia
FDA product code KET
Device type Filters, Cell Collection, Tissue Processing
Device class Class 1
Regulation 21 CFR 864.3010
Establishment Manufacturer
Premarket notification Exempt
Record published 2026-03-11

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for PathTezt®
Catalogue number Size Status
GF-0825100 In distribution
NGF-0525100 In distribution
DF-2508 In distribution
PS-250 In distribution
UCF-0813100 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Caplugs/Evergreen Caplugs, Inc. 51
Bioseal Inc. Bioseal 5
cellQART® Sabeu Gmbh & Co. KG 3
cytoQ® Sabeu Gmbh & Co. KG 3
BMP Medical Single Cytology Funnel w/ White Card Biomedical Polymers, Inc. 2
ThinPrep Hologic, Inc. 2
Marketlab, Inc Marketlab Incorporated 2
BMP Medical Metal Cytology Clip Biomedical Polymers, Inc. 1
Single Cytology Funnel w/ Brown Card Biomedical Polymers, Inc. 1
Graft Processing Board Cole Instruments 1
Cellpreserv Kolplast Kolplast C I 1
Mdhc Mdhc Life Technologies (Kunshan) Co., Ltd. 1

Showing 12 of 18. All products under Filters, Cell Collection, Tissue Processing

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer