PathTezt®

Partially removes non-diagnostic debris and excess inflammatory cells increasing the detection of epithelial cell abnormalities from the sample.

Registry build 21.09.26
2manufacturers in China registered for this device type
17catalogue numbers in this listing

Who Else Makes It

Concentrated in Hubei (1), Shaanxi (1).

Chinese manufacturers registered for FDA product code LEA
Manufacturer City Province Registered as Device types
Wuhan Landing Intelligence Medical Co., Ltd. Wuhan Hubei Manufacturer 17
Xian Tianlong Science AND Technology Co., Ltd. Xi’An Shaanxi Manufacturer 8

Record

Regulatory record for PathTezt®
Listed by Biocytech Corporation SDN BHD, Malaysia
FDA product code LEA
Device type Preservative, Cytological
Device class Class 1
Regulation 21 CFR 864.4010
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
PCS-200910E In distribution
PCS-200901E In distribution
PCS-200920 In distribution
NGPCS-200920 In distribution
EV-60010 In distribution
PCS-200920E In distribution
EV-61000 In distribution
EV-60005 In distribution
PCS-200903E In distribution
PCS-200905E In distribution
PCS-200910 In distribution
PCS-200901 In distribution
PCS-200905 In distribution
UCPCS-200920 In distribution
PCS-926 In distribution
PDR-1000 In distribution
PCS-200903 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Epredia Richard-Allan Scientific LLC 28
ThinPrep Hologic, Inc. 12
Streck Cell Preservative Streck LLC 4
Leica Biosystems Leica Biosystems Richmond, Inc. 2
BD CytoRich™ Clear Preservative Becton, Dickinson AND Company 1
MES: Freeze Medium Lonza Walkersville, Inc. 1
Pre-prcs Prtm Frz Sol 131P0103, 50L drum Lonza Walkersville, Inc. 1
Supmedic Supmedics Inc. 1
Fisherbrand Fisher Scientific Company L.L.C. 1

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