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As specified in regulations at 419.66(b)(1) through (3), to be eligible for transitional pass-through payment under the OPPS, a device must meet the following criteria: If required by FDA, the device must have received FDA approval or clearance and FDA marketing authorization (except for a device that has received an FDA investigational device exemption (IDE) and has been classified as a Category B device by FDA), or meet another appropriate FDA exemption

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Room-temperature exposure for extended periods may reduce potency by 10-15% per month, depending on light exposure and humidity

3.1.4 Human kallikrein 6 (hK6) Human kallikrein 6 is a CNS member of the serine protease family