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
- 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.
- 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