RD Biomed registers reflux disease testing device with FDA — 4 key notes

RD Biomed registered its reflux disease testing device Peptest with the FDA, Inside Media Limited reports.

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Here’s what you should know:

1. Peptest is a noninvasive, diagnostic medical device. It detects pepsin, a stomach enzyme, through clinical samples like saliva.

2. RD Biomed registered Peptest as a low-risk class 1 medical device.

3. The company is in the process of registering the test with the Chinese FDA, as well as with regulatory agencies in Taiwan, Brazil and Singapore.

4. RD Biomed Director Peter Dettmar said in a release, “We’re delighted that Peptest is now registered with the Food and Drug Administration in the US. The launch of Peptest in this market is an important step in our journey.”

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