Exact Diagnostics BKV Urine LOD #BKVULOD

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BKV Urine LOD

Overview

Material used to determine the analytical sensitivity of the assay for Polyomavirus BK Virus (BKV) DNA in Urine (10 x 1.0 mL)

Safety Data Sheet

Safety Data Sheet

Description

Description

Exact Diagnostics BKV Urine LOD Summary
Catalog Number BKVULOD
Analyte Inactivated BKV
Source Material Whole Virus
Matrix Stabilized Human Urine
Storage -70°C or Below
Shelf Life 24 Months from Date of Manufacture
Fill Volume 1.4 mL per Vial
Number of Uses Single Use
Number of Vials Per Kit 10 Vials
Traceability 1st WHO International Standard
Precautions Biological Risks
Regulatory Status In Vitro Diagnostic Use


INTENDED USE:
The Exact Diagnostics BKV Urine LOD is calibrated against the 1st WHO International Standard for BK Virus (BKV) (14/212)1 . This product is used to determine the analytical sensitivity of the assay for Polyomavirus BK Virus (BKV) DNA in human urine and allows laboratories to evaluate their molecular assay and test for operator proficiency.

PRODUCT DESCRIPTION:
The Exact Diagnostics BKV Urine LOD contains whole, intact virus that has been heat inactivated. The control is intended to test the entire process of a molecular assay including extraction, amplification, and detection. This product is formulated in stabilized human urine. Human urine is non-reactive for HBV DNA, HCV RNA, HIV-1 RNA, HBsAg and antibodies for HIV-1/2, and HCV.

Documents

Documents

Number Description Options
Q-1673
Exact Diagnostics products catalog