Exact Diagnostics HBV 1E3 IU/mL Precision #HBVL201

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HBV 1E3 Precision

Overview

Precision panel used to determine the accuracy of the assay for the presence of Hepatitis B Virus (HBV) DNA at the target concentration of 1E3 IU/mL. (9 x 1.4 mL)

Safety Data Sheet

Safety Data Sheet

Description

Description

Exact Diagnostics HBV 1E3 IU/mL Precision Summary
Catalog Number HBVL201
Analyte Inactivated HBV
Matrix True EDTA Plasma
Preservative ProClin® 300
Storage -20°C or Below
Fill Volume 1.4 mL
Number of Vials Per Kit 9 Vials
Number of Uses Single Use
Shelf Life 24 Months from Date of Manufacture
Traceability 2nd WHO International Standard
Precautions Biological Risks
Regulatory Status In Vitro Diagnostic Use


INTENDED USE:
The Exact Diagnostics HBV 1E3 IU/mL Precision is calibrated against the 2nd WHO International Standard for Hepatitis B (97/750)1. The Exact Diagnostics HBV 1E3 IU/mL Precision is used to determine the accuracy of the assay for the presence of Hepatitis B Virus (HBV) DNA at the target concentration of 1E3 IU/mL. Routine use of the Exact Diagnostics HBV 1E3 IU/mL Precision allows laboratories to evaluate their molecular assay and test for operator proficiency.

PRODUCT DESCRIPTION:
The Exact Diagnostics HBV 1E3 IU/mL Precision contains whole, intact virus that has been heat inactivated. The Exact Diagnostics HBV 1E3 IU/mL Precision is intended to test the entire process of a molecular assay including extraction, detection, and amplification.

The Exact Diagnostics HBV 1E3 IU/mL Precision is reported in International Units per milliliter (IU/mL). The Exact Diagnostics HBV 1E3 IU/mL Precision is formulated in True EDTA Plasma that 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