Waived Fentanyl Options

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Hello,

I'm looking for a waived option for Fentanyl testing. Possibly dipstick testing. Any recommendations? 

Thank you in advance. 

3 Replies

Alexis,
When I'm looking for a test for a particular complexity, I use the FDA Medical Device Database for test complexity.  Since the FDA decides which test has which complexity it is very reliable and helps to turn away some zealous sales folks who do not actually know if their own device is waived, nonwaived or approved at all. Looking at Fentanyl/Nor Fentanyl (the metabolite of Fentanyl)  and waived there are not any tests. 
CLIA - Clinical Laboratory Improvement Amendments (fda.gov)

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Thank you, Charles. Very helpful. 

Ryan, a NC company just got FDA approval for a device to detect fentanyl but it is of moderate complexity.
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Alexis Bryan
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