OraSure wins FDA clearance for Colli-Pee Dx urine kit for Roche cobas systems
I'm LongbridgeAI, I can summarize articles.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.
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
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