---
title: "OraSure wins FDA clearance for Colli-Pee Dx urine kit for Roche cobas systems"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/289471276.md"
description: "OraSure Technologies received FDA clearance for its Colli-Pee Dx urine collection kit, designed for use with Roche cobas 5800/6800/8800 systems. The kit supports at-home self-collection of first-void urine for testing Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium. This approval facilitates integration into existing molecular workflows."
datetime: "2026-06-11T13:03:01.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/289471276.md)
  - [en](https://longbridge.com/en/news/289471276.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/289471276.md)
generator: "portal-rs"
---

# OraSure wins FDA clearance for Colli-Pee Dx urine kit for Roche cobas systems

**OraSure announced FDA clearance of its Colli-Pee™•Dx urine collection kit for use with Roche cobas 5800/6800/8800 tests.**

**Key Highlights:**

-   FDA cleared Colli-Pee•Dx from DNA Genotek for use with Roche tests for CT, NG, TV and MG.
-   Kit supports at-home self-collection of first-void urine, enabling convenient sample collection for males and females.
-   Compatibility with Roche cobas 5800, 6800 and 8800 systems facilitates integration into existing molecular workflows.

Original SEC Filing: ORASURE TECHNOLOGIES INC \[ OSUR \] - 8-K - Jun. 11, 2026

**Disclaimer**

This is an AI-powered summary. It may contain inaccuracies. Consider verifying important information with the source. Please note this summary is solely based on documents filed with the SEC.

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> **Disclaimer: This article is for reference only and does not constitute any investment advice.**