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

CTS Charlotte Lab Implements WNV Testing on the Panther

CTS Charlotte Lab successfully implemented WNV NAT testing on the Panther Testing Platform on Monday...

Read More >

Pooled Zika Testing and New CTS Website Functionality- November 29th Update

As previously mentioned in Zika communications distributed on September 21 and October 12, 2018; ord...

Read More >

CTS to Implement Licensed Babesia testing

In response to the FDA guidance document for Babesia, CTS will implement the licensed Grifols  ...

Read More >

CTS Dallas and Phoenix Labs Implements WNV Testing on the Panther

CTS Dallas and Phoenix Labs successfully implemented WNV NAT testing on the Panther Testing Platform...

Read More >

Join us for a Babesia webinar!

As communicated on January 21, 2020, CTS will implement the licensed Grifols Babesia test for sample...

Read More >

FDA Releases ZIKV Guidance and Grifols ZIKV Assay Licensed- August 8th Update

CTS communications distributed on July 6th and July 20th.In working with Grifols on the availability...

Read More >