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Procleix WNV/Babesia Quality Control

Babesia Positive Control · Grifols Diagnostic Solutions Inc.

Procleix WNV/Babesia Quality Control, a set of quality controls, is intended for use as an external assayed quality control material to monitor the performance of the qualitative detection of RNA from Babesia microti and West Nile Virus (WNV) with the Procleix Babesia Assay and Procleix WNV Assay respectively performed on the Procleix Panther System.

Details

Device typeMultiple Babesia species nucleic acid IVD, control: A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple species of the Babesia protozoa (e.g., B. microti, B. duncani, B. divergens and B. venatorum) in a clinical specimen.

FDA categoryAssayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening.

Device ID00850032683050

AvailabilityPrescription

Single useYes

MRI safetyLabeling does not contain MRI Safety Information

Contact

Phone1-800-452-6877

Emailservice.americas@grifols.com

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