Please Wait a Moment
X

Articles

10Jul

FDA Guidance for Industry for Babesia

10 Jul, 2019 | Return|

On May 9, 2019 the Food and Drug Administration issued a “Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis” guidance document with a maximum 12 month implementation timeline. Per the FDA guidance document recommendations, CTS is developing a specific implementation plan for mandatory Babesia testing well before the May 8, 2020 deadline.

 

Check out the Communication page for the complete details by clicking the link: Communications

Related

Seasonal Monitoring for WNV to begin June 1, 2019

Seasonal monitoring of epidemic triggers for West Nile Virus (WNV) NAT tested donations will begin J...

Read More >

Exhibiting at AABB Annual Meeting- Booth 732

We sincerely hope to see you at this year’s AABB Annual Meeting in San Antonio, TX on October ...

Read More >

Reminder-Confirmatory Algorithm and Assay Changes Effective September 30, 2019

On June 13, 2019, CTS provided information regarding the manufacturer’s discontinuation of HIV...

Read More >

Seasonal Monitoring for WNV to begin June 1, 2020

Seasonal monitoring of epidemic triggers for West Nile Virus (WNV) NAT tested donations will begin J...

Read More >

CTS Tampa Implementation date change for Ultrio Elite

CTS originally communicated that Tampa will convert from the current Grifols Ultrio Plus NAT triplex...

Read More >

Update on CTS Implementation of the Grifols Procleix Ultrio Elite Assay

In July, all 5 CTS laboratories will convert from the current Grifols Ultrio Plus NAT triplex assay ...

Read More >