FDA: Label Requirements for General Purpose Reagents IVD

  • Thread starter AbsoluteBeginner
  • Start date
A

AbsoluteBeginner

#1
Hello all!

I need some information about the label requirements for General Purpose Reagens. Can anybody help me? I have "only" found the label requirements for the Anaylte Specific Reagens...

Thanks a lot in advance!! :agree1:
 
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Stijloor

Leader
Super Moderator
#2
Re: FDA: Label Requirements for General Purpose Reagens IVD

A Quick Bump!

Can someone help?

Thank you very much!!

Stijloor.
 

Marc

Fully vaccinated are you?
Leader
Admin
#3
Re: FDA: Label Requirements for General Purpose Reagens IVD

One more quick "Bump". My thanks in advance to anyone who can help with this one.
 

sreenu927

Quite Involved in Discussions
#6
Hi..
Another interesting question I have is as below:
We are manufacturing an empty calibration plate (that will have 48wells, 96wells, etc..). We would like to sell these empty hard shell plates to both RUO and IVD customers. The customers will then add their own chemistry and perform calibration of the instruments. These plates are sold separately, NOT as part of the instrument system.

As no chemistry inside, the "General Purpose Reagent" label is not applicable.

If I label as "For in vitro diagnostic use only or IVD symbol", I can sell it for both RUO and IVD purposes. However, I need to list as Class I medical device with FDA and the controls are more.

So in this regard, if I label them as "For laboratory Use" or "General Purpose Laboratory Equipment" can I then sell for both RUO and IVD purposes, so that the listing with US FDA may still requires, but the controls are less (label and complaint MDR files) when compared to listing the device as Class I (Complete QSR).

Thanks,
Sreenu
 
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