Specifications
CLASS
Lateral-flow Immunoassays
COUNTRY OF ORIGIN
United States
PRECAUTIONARY STATEMENTS
For in vitro diagnostic use only. Do not use expired test. Do not use if the pouch seal is compromised. Do not open the sealed pouch until ready to perform the ADEXUSDx® Syphilis Test. Read the Product Insert completely before using this assay. Follow the instructions carefully. Failure to follow instructions may result in inaccurate test results.
*USAGE / SAFETY STATEMENT
The ADEXUSDx® Syphilis Test is a rapid immunochromatographic assay used for the qualitative detection of the presence or absence of antibodies to syphilis in human whole blood, plasma, or serum to aid in the diagnosis of Treponema pallidum
REGULATORY NOTICE & RESTRICTIONS
For in vitro diagnostic use only. Do not use expired test. Do not use if the pouch seal is compromised. Do not open the sealed pouch until ready to perform the ADEXUSDx® Syphilis Test. Read the Product Insert completely before using this assay. Follow the instructions carefully. Failure to follow instructions may result in inaccurate test results.
QUALITY CERTIFICATION / COMPLIANCE
This product was manufactured in NOWDiagnostics, Inc. facilities based on a quality system compliant with GMP for Medical Devices and ISO 13485.
RESULT WINDOW
15-30 Minutes
SAMPLE TYPE
Human venous whole blood, plasma, and serum
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