Babesia microti NAT/Babesia microti NAT for Blood Screening

STN:  BL 125588
Proper Name: Imugen Babesia microti Nucleic Acid Test (NAT)
Tradename: Babesia microti NAT/Babesia microti NAT for Blood Screening
Manufacturer: Oxford Immunotec Ltd
Indication:  

• Intended for use as a donor screening test to detect Babesia microti DNA in whole blood samples from individual human donors, including volunteer donors of whole blood and blood components, as well as other living donors.  It is also intended for use to screen organ and tissue donors when specimens are obtained while the donor’s heart is still beating.

Supporting Documents

• March 6, 2018 Summary Basis for Regulatory Action - Imugen Babesia microti NAT
• March 6, 2018 Approval Letter - Babesia microti NAT/Babesia microti NAT for Blood Screening
• Approval History, Letters, Reviews, and Related Documents - Imugen Babesia microti NAT

Related Information

• FDA approves first tests to screen for tickborne parasite in whole blood and plasma to protect the U.S. blood supply
  Press Release: 3/6/2018
• Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays
• Babesia microti AFIA/Babesia microti AFIA for Blood Donor Screening