Roche’s Receives the US FDA’s Clearance for Urine Sample Type for BK Virus Quantitative Test

February 15, 2021 Auto Bot Clearance, FDA, MedTech, receives, Roche 0

Shots:

  • The US FDA 510K clearance for stabilized urine samples to be used with the cobas BKV test on the cobas 6800/8800 systems. It is also approved for use in CE markets with EDTA plasma and urine stabilized in cobas PCR media as sample types
  • The cobas BKV test provides an alternative to LDTs or ASR combinations, reducing variability and complexity in testing as well as workload and risk alleviation for labs
  • The test previously received the US FDA’s BTD and cleared for use with EDTA plasma samples to aid in the management of BKV in transplant patients and also delivers enhanced diagnosis of disease via non-invasive, easily collected, prepared and stored urine samples

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Cladding Corp

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