RE: [Histonet] RUO OR ASR

From:"Morken, Tim"

Joyce, Just to clarify, when you say the ASR is " not approved by FDA"
you make it seem they cannot be used by a diagnostic lab. But the ASR
designation was specifically implemented to allow diagnostic labs to use
antibodies that had not been fully validated by the company that sells
it and puts the onus of validation on the lab that uses it. The company
must be FDA-registered to sell ASR's and only CLIA-approved diagnostic
labs can use ASR's as diagnostic devices. The ASR does require a notice
that it is not FDA approved, but the lab can also attach a notice that
ASR's do not require FDA approval. 

Tim Morken
Lab Vision - Neomarkers
ThermoFisher Scientific

-----Original Message-----
[] On Behalf Of Weems,
Sent: Monday, January 08, 2007 3:09 PM
To: Akemi Allison-Tacha;
Subject: RE: [Histonet] RUO OR ASR

Analyte Specific Reagent - not approve by FDA...

-----Original Message-----
[]On Behalf Of Akemi
Sent: Monday, January 08, 2007 6:03 PM
Subject: [Histonet] RUO OR ASR

Hi All,
  I hate to show my stupidity, but I must be a little out of the loop on
these.  I know that RUO means research use only, but what does ASR mean?
Don't shoot me down in flames guys!  
  Akemi Allison-Tacha, BS, HT(ASCP)HTL
Phoenix Lab Consulting & Staffing
  Specializing in Histology & TMA
  Madison, WI
Cell: (925) 788-0900

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