
Kallestad Laboratories, Inc.
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PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS is an FDA 510(k)-cleared medical device (K853554) manufactured by Kallestad Laboratories, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 25, 1985. Regulation: 8.

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