IVD products that are labeled as Analyte Specific Reagent (ASR)

I

Imecoli

#1
I was wondering if any other countries recognize our IVD products as ASRs? (we are registered with FDA and ISO 13485 certified and have a presence in EU to sell CE products) I know we can ship our CE registered products to the EU countries for clinical studies but someone told us we could sell our ASRs to other countries and they would be recognized as such. My understanding is that the ASR labeled product are only recognized as clinical worthy in the US. does anyone have any feedback for me here? any help would be greatly appreciated. I have checked with CBER and FDA websites but not much luck there.

Thank you,
Matt
 
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sreenu927

Quite Involved in Discussions
#2
Re: IVD products that are labled as ASR

Except US, no other country recognises ASRs. Those countries consider either RUO (Research Use Only) or IVD (In vitro diagnostic products).

Regards,
Sreenu:2cents:
 
I

Imecoli

#3
Re: IVD products that are labled as ASR

Thanks for the reply, I was pretty certain, but your response gave me 100% certainty.
 
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