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  • 1.  General purpose reagent

    This message was posted by a user wishing to remain anonymous
    Posted 30-Aug-2022 13:58
    This message was posted by a user wishing to remain anonymous

    Hello Regex, 

    Is General Purpose Reagent exempt from UDI  requirements? 

    Thank you in Advance.


  • 2.  RE: General purpose reagent

    Posted 31-Aug-2022 02:49
    Always start at the beginning: is it a device or not? And under what legislation are you asking this question in the first place? Please be precise to get a useful answer.

    Article 1 (3) (a) IVDR provides that products for general laboratory use or research-use only products, unless such products, in view of their character istics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination. So here's the question for you to answer. If it's a device, it needs UDI. If not, it does not need UDI. There is no definition of a general purpose reagent under the IVDR.

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    Erik Vollebregt
    Partner
    Amsterdam
    Netherlands
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    Original Message


  • 3.  RE: General purpose reagent

    Posted 31-Aug-2022 04:32
    Anon.

    Depends on what jurisdiction you are speaking about and exactly what "general purpose reagent" means as well.  There are different classifications and groupings of products in different countries and some UDI requirements exist today with more coming in the future.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: General purpose reagent

    This message was posted by a user wishing to remain anonymous
    Posted 01-Sep-2022 09:15
    This message was posted by a user wishing to remain anonymous

    Hi both, thank you for your response.

    General purpose reagent - device for collection of samples for IVD kit. Class I. FDA.  What are the UDI requirements in the US?

    Original Message


  • 5.  RE: General purpose reagent

    Posted 01-Sep-2022 22:00
    Most devices will need UDIs. US FDA has an overview of the UDI requirements here:

    https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/udi-basics


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    Anne LeBlanc
    United States
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    Original Message


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