LDX notifications to FDA
Just wanted to share a list of labs that have notified FDA that they have Laboratory-developed monkeypox tests - so you are aware, and ask whether you are receiving ELR from these labs for these tests? THANK YOU!
See https://www.fda.gov/medical-devices/emergency-situations-medical-devices/monkeypox-and-medical-devices?utm_medium=email&utm_source=govdelivery#Laboratories
Need to scroll down to get to the table of the labs - and you can download an excel file.
See https://www.fda.gov/medical-devices/emergency-situations-medical-devices/monkeypox-and-medical-devices?utm_medium=email&utm_source=govdelivery#Laboratories
Need to scroll down to get to the table of the labs - and you can download an excel file.
From this list, Florida is receiving from
* ARUP Laboratories, Inc.
* BayCare Laboratories, LLC
* BioReference Health, LLC
* Johns Hopkins Medical Microbiology Laboratory
* Tampa General Hospital Clinical Laboratory - Esoteric Testing Department
We're also currently onboarding
* CDR Laboratories, Inc
* Curative Labs
* Nomi Health Laboratory Services LLC
Nicole Kikuchi, MPH, CPM
Florida Department of Health
E-mail: Nicole.Kikuchi@flhealth.gov<mailto:Nicole.Kikuchi@flhealth.gov>
ARUP
BioReference
Memorial Sloan Kettering
Montefiore Medical Center
NY Presby
NYU Langone
Wadsworth
Thanks.
David DiCesare
NYS ELR Coordinator
ECLRS Help Desk
Bureau of Surveillance and Data Systems
Local - 518-402-5943
Long Distance - 866-325-7743
David.dicesare@health.ny.gov