
Cepheid
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Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System is an FDA 510(k)-cleared medical device (K203429) manufactured by Cepheid. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 8, 2022. Regulation: 8.

ADC
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3M Littmann
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Welch Allyn
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