
Qiagen, Inc.
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ipsogen JAK2 RGQ PCR Kit is an FDA 510(k)-cleared medical device (K172287) manufactured by Qiagen, Inc.. This device is classified under the Medical Genetics specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 11, 2018. Regulation: 8.