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Under the clearance, capillary whole blood is no longer an acceptable sample type for the company's Blue i-Stat CG4+ cartridge.
The revisions include information on demonstrating accuracy and how to design a single set of comparison and reproducibility studies for dual 510(k) and CLIA waiver submission.
The University of Utah spinout said it will use the funding to enhance and expand its NGS-based Explify microbe identification platform and support its lab.
The company reported performance changes that led to the product recall and said it is pursuing eventual FDA clearance for the devices.
With the certification, the Silicon Valley-based company aims to roll out its AvaGen test for keratoconus and corneal dystrophies beginning this quarter.
The company's Acucy Influenza A&B test detects viral nucleoprotein antigens from nasal and nasopharyngeal swabs.
The lab can now receive US specimens for testing with its LiquidHallmark blood test that detects cancer-causing gene mutations and viruses.
The biotech company focuses on early cancer screening and detection and sells a multi-cancer screening and detection test in China.
As regulatory changes and technical advances reshape the clinical lab, directors are seeing a shift in responsibilities and the expertise required for the job.
The firm said it needs more time to ensure that the DetermaVu assay is providing the most consistent and sensitive results for patients.