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

FDA announces withdrawal of Guidance for ZIKV Testing

We are informing you that the FDA has announced their withdrawal of Guidance for ZIKV Testing. In th...

Read More >

COVID-19 Antibody Testing Frequently Asked Questions

The recent communication regarding the recent Anti-SARS-CoV-2 Total assay in Tampa has brought about...

Read More >

IPFA welcomes Marion Lanteri as Executive Board member, CTS as new member organization

IPFA welcomes Marion Lanteri as Executive Board member, CTS as new member organization

Read More >

CTS St. Louis Implements New Laboratory Information System

On August 9, 2019, the new CTS Laboratory Information System was successfully implemented in St...

Read More >

CTS conversion to the Ortho VERSEIA Integrated Processor (VIP) in January 2021

After a thorough and comprehensive review of proposals received from suppliers of viral marker testi...

Read More >

Reminder- Health and Human Services (HHS) email notifications for WNV reactives

Reminder test emails for the Health and Human Services (HHS) email notifications for WNV reactives h...

Read More >