Molecular Diagnostic Control Set Savanna® HSV 1+2/VZV Positive Level / Negative Level

Name: Control Set
Brand: Savanna®

CONTROL SET, SAVANNA HSV1+2/VZV ASSAY (1/KT) D/S

McKesson #

1244163

Manufacturer #

M409-1

Brand

Savanna®

Manufacturer

Quidel

Country of Origin

United States

Application

Control Set

Buy American Act (BAA) Compliant

Yes

Container Type

Vial

For Use With

For Savanna Instrument

Form

Swab

Levels

Positive Level / Negative Level

Test Category

Sexual Health

Test Name

HSV 1+2/VZV

Test Type

Molecular Diagnostic

Trade Agreement Act (TAA) Compliant

Yes

UNSPSC Code

41116145

The Savanna HSV 1+2/VZV Assay Control Set is intended to be used to monitor the performance of the Savanna HSV 1+2/VZV Assay
These controls provide an aid in the interpretation of positive and negative test results and verify proper test performance
The Control Set contains a pouched Positive Swab and two buffer tubes for use in verifying the performance of the Savanna HSV 1+2/VZV Assay
Set contains: Two (2) vials of control buffer (1.0 mL per vial): Contain Tris buffered EDTA solution, with sodium azide, One (1) Positive Swab Mylar pouch: Contains a Positive Swab (positive, desiccated and inactivated human pathogen, or part thereof) with targets for herpes simplex virus type 1, herpes simplex virus type 2 and varicella-zoster virus, with desiccant, Quality Control (QC) Barcode Card (1) specific to the Savanna HSV 1+2/VZV Assay: Barcode for the Negative Control on one side and barcode for the Positive Control on the other side, and Package Insert (1) (with kit or available electronically)