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Roche’s STI assay panels gain FDA 510(k) clearance and CLIA waiverDesigned for ease of use in near-patient settings, the cobas liat assays require minimal training, ensuring rapidness for healthcare professionals. The closed system design of cobas liat also ...
The test, one of the first of its kind, is designed to reach patients who may forgo traditional screening because of lack of ...
The US Food and Drug Administration (FDA) has approved Roche’s cobas epidermal growth factor receptor (EGFR) Mutation Test v2. The decision makes it the first FDA-approved, blood-based genetic ...
The new test is compatible with Roche's cobas 5800, 6800, and 8800 molecular diagnostic analysers, which are widely used in hospitals and other clinical settings, without any need for upgrades.
According to GlobalData, these tariffs are expected to impact all 510(k)-approved medical devices manufactured outside of the ...
The new offering utilizes the FDA-cleared HPV self-collection solution from Roche (SIX: RO, ROG; OTCQX: RHHBY), approved for use with Roche's cobas® HPV test in May 2024. Interested patients can ...
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