Datametrex AI Ltd V.DM

PENDING HEALTH CANADA REVIEWS...

[MoreUpThanDown]

Based on the Covid tests listed on DM's website, there are still another 3 at this time that are awaiting a decision from Health Canada... 1) U--TOP, Nucleic Acid Technology Lab-based test by Seasun Biomaterials is "Under Review".... 2) iLamp, Nucleic Acid Technology Lab-based test by iONEBIO is "Awaiting response from manufacturer"... and 3) BIOCredit, Antigen Technology Point Of Care Test by RapiGen Inc. is "Under Review". Hoping these are approved in the near future. Up to Health Canada at this point... All IMO. DYODD.

[dirtydzn]

I believe they're waiting on that 5 minute home test and the WIZCHEM saliva based test as well.

[Wormi12345]

The WIZCHEM saliva test ist already approved by HC.

[dirtydzn]

When was it approved by Health Canada? They acquired the rights on February 3rd, 2021 with FDA and CE certification. I have not seen any mention of HC approval since.

[MoreUpThanDown]

Hi Wormi. Could you share your source please? Thank you.

[swyint123888]

Looks like still pending for sure in Canada WIZCHEM has secured U.S. FDA EUA, CE mark certification, and is Good Manufacturing Practice (GMP) facilities compliant. These tests are manufactured the with permission from the Korean FDA based on ISO 13485, and sold globally. Each of the manufacturers' medical devices will be submitted to Health Canada ("HC") for approval on a fast track

[MoreUpThanDown]

Agreed. But to keep it real, these test waiting for HC would all be in addition to what is already approved by HC and should allow for even more volume, if approved by HC and then if ordered. DM's doing very well with the test kits already approved by HC, I believe. All IMO. DYODD.

[MoreUpThanDown]

Was hoping to see that... It's not listed on DM's website... Not on the awaiting approval list nor on the authorized list; that I can find anyhow.... maybe authorized for other countries though. All IMO. DYODD.

[MoreUpThanDown]

... Update to the original post below... the iLamp, Nucleic Acid Technology Lab-based test by iONEBIO is no longer "Awaiting response from manufacturer" but is now "Under Review"..... one small step, but still a step........the other 2 remain the same.........ORIGINAL POST: Based on the Covid tests listed on DM's website, there are still another 3 at this time that are

[MoreUpThanDown]

... Update to the original post below... the U--TOP, Nucleic Acid Technology Lab-based test by Seasun Biomaterials is no longer "Under Review" but is now "Awaiting response from manufacturer" ..... another small step, but still a step........the other 2 remain "Under Review" noting that the iLamp already had a response requested from the manufacturer, which must have