[Histonet] What about RUO antibodies

[soofia siddiqui]

Is it appropriate to use the RUO antibodies for diagnostic purpose in a CLIA certified lab? Any feed back greatly appreciated. Thank you in advance.
   Soofia 

"Weems, Joyce" <JWEEMS <@t> sjha.org> wrote:
  Thanks Tim!

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu
[mailto:histonet-bounces <@t> lists.utsouthwestern.edu]On Behalf Of Morken,
Tim
Sent: Monday, January 08, 2007 6:22 PM
To: Histonet <@t> lists.utsouthwestern.edu
Subject: RE: [Histonet] RUO OR ASR


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-----
From: histonet-bounces <@t> lists.utsouthwestern.edu
[mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Weems,
Joyce
Sent: Monday, January 08, 2007 3:09 PM
To: Akemi Allison-Tacha; Histonet <@t> lists.utsouthwestern.edu
Subject: RE: [Histonet] RUO OR ASR

Analyte Specific Reagent - not approve by FDA...

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu
[mailto:histonet-bounces <@t> lists.utsouthwestern.edu]On Behalf Of Akemi
Allison-Tacha
Sent: Monday, January 08, 2007 6:03 PM
To: Histonet <@t> lists.utsouthwestern.edu
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! 

Sincerely,

Akemi Allison-Tacha, BS, HT(ASCP)HTL
President
Phoenix Lab Consulting & Staffing
Specializing in Histology & TMA
Madison, WI
E-Mail: akemiat3377 <@t> yahoo.com
Cell: (925) 788-0900


_______________________________________________
Histonet mailing list
Histonet <@t> lists.utsouthwestern.edu
http://lists.utsouthwestern.edu/mailman/listinfo/histonet


Confidentiality Notice ** The information contained in this message may
be privileged and is confidential information intended for the use of
the addressee listed above. If you are neither the intended recipient
nor the employee or agent responsible for delivering this message to the
intended recipient, you are hereby notified that any disclosure,
copying, distribution or the taking of any action in reliance on the
contents of this information is strictly prohibited. If you have
received this communication in error, please notify us immediately by
replying to the message and deleting it from your computer. Thank you.
Saint Joseph's Health System, Inc.

_______________________________________________
Histonet mailing list
Histonet <@t> lists.utsouthwestern.edu
http://lists.utsouthwestern.edu/mailman/listinfo/histonet


Confidentiality Notice ** The information contained in this message may be privileged and is confidential information intended for the use of the addressee listed above. If you are neither the intended recipient nor the employee or agent responsible for delivering this message to the intended recipient, you are hereby notified that any disclosure, copying, distribution or the taking of any action in reliance on the contents of this information is strictly prohibited. If you have received this communication in error, please notify us immediately by replying to the message and deleting it from your computer. Thank you. Saint Joseph's Health System, Inc.
_______________________________________________
Histonet mailing list
Histonet <@t> lists.utsouthwestern.edu
http://lists.utsouthwestern.edu/mailman/listinfo/histonet


 __________________________________________________
Do You Yahoo!?
Tired of spam?  Yahoo! Mail has the best spam protection around 
http://mail.yahoo.com