Procleix Babesia Assay

STN# 125673
Proper Name: Procleix Babesia Assay
Tradename: Procleix Babesia Assay
Manufacturer: Grifols Diagnostics Solutions Inc.
Indication:

• The Procleix® Babesia Assay is a qualitative in vitro nucleic acid amplification test for the detection of RNA from Babesia species (B. microti, B. duncani, B. divergens, and B. venatorum) in whole blood specimens.

Product Information

• Package Insert - Procleix Babesia Assay

Supporting Documents

• December 16, 2025 Approval Letter - Procleix Babesia Assay
• December 5, 2024 Approval Letter - Procleix Babesia assay
• November 20, 2020 Approval Letter - Procleix Babesia Assay
• February 12, 2020 Approval Letter - Procleix Babesia Assay
• January 24, 2019 Approval Letter – Procleix Babesia Assay
• January 18, 2019 Summary Basis of Regulatory Action - Procleix Babesia Assay