NAME AND INTENDED USE
The GS HBsAg Confirmatory Assay 3.0 is a qualitative assay intended for the confirmation of HBsAg reactive specimens detected in the GS HBsAg EIA 3.0.
WARNINGS FOR USERS
- For In Vitro Diagnostic Use.
- Wear protective clothing, including lab coat, eye/face protection and disposable gloves (synthetic, non-latex gloves are recommended) while handling kit reagents. Wash hands thoroughly after performing the test.
- Do not smoke, drink, or eat in areas where specimens or kit reagents are being handled.
- Do not pipette by mouth.
- This test kit should be handled only by qualified personnel trained in laboratory procedures and familiar with their potential hazards. Wear appropriate protective clothing, gloves and eye/face protection and handle appropriately with the requisite Good Laboratory Practices. The following is a list of potential chemical hazards contained in kit components:
- ProClin™ 950 (0.16%), a biocidal preservative that is irritating to eyes and skin, may be detrimental if enough is ingested, and may cause sensitization by skin contact; prolonged or repeated exposure may cause allergic reaction in certain sensitive individuals.
- 0.005% Gentamicin Sulfate, a biocidal preservative, which is a known reproductive toxin, photosensitizer and sensitizer; prolonged or repeated exposure may cause allergic reaction in certain sensitive individuals.
EIA test for confirmatory neutralization of Hepatitis B Surface Antigen (HBsAg) reactive specimens. This is a 25 test kit.