Great Basin makes 510(k) submission to US FDA for whooping cough test
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Great Basin Scientific Inc. made a 510(k) submission to the U.S. FDA for its bordetella direct test.
The company's sample-to-result test detects bordetella pertussis, commonly known as whooping cough, identifying the bacterium behind the highly contagious respiratory disease.
Great Basin is also seeking a CE mark for the test.
