Product Manual
Page 2 of 4
FOR INFORMATIONAL USE ONLY
FOR INFORMATIONAL USE ONLY
Not to be used for performing assay. Refer to most current package insert accompanying your test kit.
iFOB Control Set
WARNINGS AND PRECAUTIONS
For In-Vitro Diagnostic Use.
Do not use beyond labeled expiration date marked on the outer kit label.
Do not interchange the caps with those of other reagent bottles.
Dispose of containers and used contents in accordance with Federal, State, and
Local requirements.
Use of Nitrile or Latex gloves is recommended when working with these controls.
Follow proper hand washing hygiene after handling these controls.
The External Controls are designed for use only with the QuickVue iFOB test.
These components may contain material of human origin, which has been tested using
FDA-approved methods and has been found negative to human immunodeciency
virus (HIV-I and HIV-II), antibody to Hepatitis C virus and for Hepatitis B surface antigen
(HbsAg). No known test method can oer total assurance that HIV-I and HIV-II, Hepatitis
B virus, Hepatitis C virus or other infectious agents are absent. HANDLE THESE
REAGENTS AS IF THEY WERE POTENTALLY INFECTIOUS.
STABILITY AND STORAGE
Store the QuickVue iFOB test Control Set at room temperature 59–86°F (15–30°C). Do not
freeze. The contents can be used until the expiration date printed on the outer box, or
four (4) weeks after the vials are opened, whichever occurs rst.
QUALITY CONTROL
External controls may be used to demonstrate that all reagents and assays are performing
properly. The QuickVue iFOB Control Set, when used in accordance with the test
procedure described in the QuickVue iFOB test package insert, provide this capability.