STN:  BL 125589
Proper Name: Imugen Babesia microti Arrayed Fluorescence Immunoassay (AFIA)
Tradename: Babesia microti AFIA/Babesia microti AFIA for Blood Donor Screening
Manufacturer: Oxford Immunotec Ltd
Indication: 

• Intended for use as a donor screening test to detect antibodies to Babesia microti in plasma 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 -Babesia microti AFIA/Babesia microti AFIA for Blood Donor Screening
• March 6, 2018 Approval Letter - Babesia microti AFIA/Babesia microti AFIA for Blood Donor Screening
• Approval History, Letters, Reviews and Related Documents - Imugen Babesia microti AFIA

Related Information

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• Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays
• Babesia microti NAT/Babesia microti NAT for Blood Screening