Axim Biotechnologies Inc (AXIM)

[TexasMarvL]

If the Lactoferrin test is a Class 1 test then by definition the Lactoferrin test is a CLIA Waived test. Why has AXIM Management not told us this???

Is there any benefit in having one Class 1 test and the other a Class 2 test?

There should be great benefit.

First and foremost ALL of our potential customers should be able to order the Lactoferrin Tests and become familiar with the test reader. Then already be familiar with the TPOC system once the IgE test is Waived.

NOTE: I believe the IgE test is currently stuck inside an FDA division where ALL tests are classified as Class 2. That could be a problem except our test is a Tear-based Point-of-Care test.




510(k) Number K934473
Device Name
LACTOFERRIN MICROASSAY SYSTEM
Date Received 09/14/1993
Decision Date 12/03/1993

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K934473

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510(k) Number. K991316
Device Name
TOUCH TEAR IGE MICROASSAY KIT
Date Received 04/19/1999
Decision Date 08/09/1999

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K991316

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