Appropriate use of the REF symbol in IVD kits and kit components

[MPiska]

Hi All,

As per the definitions in EN980 and ISO15223-1 the REF symbol is the Manufacturers Catalogue Number (aka reference number or re-order number)

We have reagents that are not sold separately, but form a part of multiple kits,as such each component does not have its own catalogue number.

On these reagents we currently include the REF symbol and then list all catalogue numbers of the kits that this reagent is present in - is this considered appropriate use of the REF symbol?

Thanks,

MP.

 

[Ronen E]

Hi All,

As per the definitions in EN980 and ISO15223-1 the REF symbol is the Manufacturers Catalogue Number (aka reference number or re-order number)

We have reagents that are not sold separately, but form a part of multiple kits,as such each component does not have its own catalogue number.

On these reagents we currently include the REF symbol and then list all catalogue numbers of the kits that this reagent is present in - is this considered appropriate use of the REF symbol?

Thanks,

MP.

Hi,

If the reagent is not offered for sale separately it should bear your own internal cat number for it. I assume you have one for process control purposes.

Cheers,
Ronen.

 

[MPiska]

Thank you, Ronen.

We use that method for several of our older products, where they are sold as a separate accessory item and as a part of a kit.

i.e
filled reagent bottle is REF XX01
The code is not the full internal REF that we use but forms a unique part of it.

Packed kit that includes reagent is REF Z1111111
Packed reagent on own as a single accessory is REF Z222222


On some of the newer kits that we have acquired due to purchases the filled reagent in this example would state REF Z1111111, Z222222


I have questioned this and been told it is acceptable but I was still not sure, hence this thread. Thank you for confirming my own beliefs.

It would be good to have some more comments before I take this back to my boss for further discussion.