PathTezt®

GUDID 09551020410092

The positive charged surface adhere the cell samples

BIOCYTECH CORPORATION SDN. BHD.

General specimen microscopy slide IVD, single-use

• Primary Device ID: 09551020410092
• NIH Device Record Key: 964c8538-f1c6-489a-9a31-4687cbf6ebe1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PathTezt®
• Version Model Number: CS-36100
• Company DUNS: 865773902
• Company Name: BIOCYTECH CORPORATION SDN. BHD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-887-846-5393
• Email: mseidel@cancerdiagnostics.com
• Phone: 1-887-846-5393
• Email: mseidel@cancerdiagnostics.com
• Phone: 1-887-846-5393
• Email: mseidel@cancerdiagnostics.com
• Phone: 1-887-846-5393
• Email: mseidel@cancerdiagnostics.com
• Phone: 1-887-846-5393
• Email: mseidel@cancerdiagnostics.com
• Phone: 1-887-846-5393
• Email: mseidel@cancerdiagnostics.com
• Phone: 1-887-846-5393
• Email: mseidel@cancerdiagnostics.com
• Phone: 1-887-846-5393
• Email: mseidel@cancerdiagnostics.com
• Phone: 1-887-846-5393
• Email: mseidel@cancerdiagnostics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	09551020410092 [Primary]

FDA Product Code

• KEW: Slides, Microscope

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-19
• Device Publish Date: 2026-03-11

On-Brand Devices [PathTezt®]

• 09551020410511: Special design effective in removal mucus and non-diagnostic materials in samples.
• 09551020410504: The filters work with an LBC processor to capture cells from PathTezt® Preserve Cell Solution a
• 09551020410498: To contain and preserve cell samples.
• 09551020410481: To contain and preserve cell samples.
• 09551020410474: Preservation and transportation of cell material from the vagina.
• 09551020410467: Preservation and transportation of cell material from the vagina.
• 09551020410450: Preservation and transportation of cell material from the vagina.
• 09551020410443: To contain and preserve cell samples.
• 09551020410436: To contain and preserve cell samples.
• 09551020410368: To protect the stained cell sample on the slide for microscopic examination.
• 09551020410351: The preclean glass slide is used as a base for cell transfer during cytological specimen prepara
• 09551020410344: The positive charged surface adhere the cell samples
• 09551020410337: The positive charged surface adhere the cell samples
• 09551020410320: The positive charged surface adhere the cell samples
• 09551020410313: The specimen is poured onto the dual filter, where suction removes debris at the first layer and
• 09551020410283: Preservation and transportation of cell material from the vagina.
• 09551020410252: Preservation and transportation of cell material from the vagina.
• 09551020410245: Preservation and transportation of cell material from the vagina.
• 09551020410238: Preservation and transportation of cell material from the vagina.
• 09551020410221: To contain and preserve cell samples.
• 09551020410146: Partially removes non-diagnostic debris and excess inflammatory cells increasing the detection o
• 09551020410115: To contain and preserve cell samples.
• 09551020410108: To contain and preserve cell samples.
• 09551020410092: The positive charged surface adhere the cell samples
• 09551020410085: The filters work with an LBC processor to capture cells from PathTezt® Preserve Cell Solution a
• 09551020410078: The filters work with an LBC processor to capture cells from PathTezt® Preserve Cell Solution a
• 09551020410054: Buffered, preservative and lysis the red-blood cell solution.
• 09551020410047: To contain and preserve cell samples.
• 09551020410030: To contain and preserve cell samples.
• 09551020410016: PathTezt® Processor Thin-layer slide preparation processor.
• 09551020410009: PathTezt® Infinity fully automated cytology slide processor with Autoloader. Fully walk away sy