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Although deviations were reported, all possible root causes were not identified to ensure that corrective actions would prevent reoccurrence, the FDA said. Read More
The disposable cartridges come with necessary reagents and accept a drop of blood from the finger, and the device provides all 20 CBC parameters. Read More
To obtain a free sale certificate, manufacturers must submit a hard copy cover letter including the list of products the certificate will cover. Read More
Accipio Ix, which received the CE Mark earlier in the year, uses AI algorithms to identify and mark potential regions of interest related to acute intracranial hemorrhage. Read More