Fentanyl urine testing

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Does anyone know if there are any POC Waived urine tests for Fentanyl? Either as part of a panel or on its own? The only test I'm seeing online is from Sefria and their website doesn't give much info on the test procedure.


 


Thanks!


Jill

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Hi,


I know this company does:


https://abmc.com/product/abmc-xpress-cup/


 


We use this cup and the Doctors are now asking to add Fentanyl. It will add $.30 to each cup to add the strip. I think you can configure how you like up to 13 or 14 tests. The fentanyl by itself as a single test was $1.03..


 


Tonya

Thank you Tonya - I've contacted the company and I"m waiting for call/email back.


Tonya,


My IT security will not allow me to follow the link you posted.  What is the name of the product/company?


Is this product waived for fentanyl?

I researched POC fentanyl testing a couple of months back and didn’t see it on the FDA list of waived tests. I saw products on the market but they had a stipulation that they could only be used for forensic purposes.

I tried calling this company twice to get info but couldn’t get through.

Sent via Groupsite Mobile.

When I contacted ABMC they told me that there was a waived Fentanyl strip that could be added (I'm not sure if it is a separate strip or added to a cup with other tests included). I'm waiting to hear more details/pricing today.

Terry - the company is American BioMedica (company? corp?). The product is the XPress Cup (waived urine drug testing cup)

Is this FDA approved?  I do not see it on the FDA list of approved tests. 

I just heard back from the sales rep - it is not waived :(  The first email from them made it sound like waived was an option. They say there is currently no waived fentanyl product on the market. 

 


Glad you got the information, I thought I was specific when I asked.


 


Tonya


I was told that most new tests are non-waived when they first get submitted to FDA.


If the company wants to market it as waived, they have to resubmit again ( more money of course)


So some companies would resubmit  but some do not.


This is what happened with PROLAB Amniotest swabs.


When they marketed it to us when they first came out,  they told us it is waived.


Come to find out they never resubmit it because of the cost.


So it stayed as a  non-waived test.


WE are now using Amniosure.  


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Jill Dwyer
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