Specifications
CLASS
Lateral-flow Immunoassays
COUNTRY OF ORIGIN
United States
PRECAUTIONARY STATEMENTS
For in vitro diagnostic use only. Dispose of expired tests and completed tests as biohazardous material. Do not use expired tests. Do not use if pouch seal is compromised. Single use only. CAUTION: The device contains material of human or animal origin and should be handled as a potential carrier and transmitter of disease.
*USAGE / SAFETY STATEMENT
The ADEXUSDx® hCG Test is an immunoassay used for the qualitative detection of human chorionic gonadotropin in human whole blood (capillary or heparinized venous), plasma, or serum and is indicated as an aid for healthcare professionals in the diagnosis of early pregnancy
REGULATORY NOTICE & RESTRICTIONS
For in vitro diagnostic use only. Dispose of expired tests and completed tests as biohazardous material. Do not use expired tests. Do not use pouch sealsis compromised. Single use only
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
10-30 Minutes
RECOMMENDED EXTERNAL CONTROLS
ADEXUSDx® hCG Control Set, Sure-Vue hCG Serum Control Set, SAS hCG Serum Control Set
SAMPLE TYPE
Human venous whole blood, fingerstick whole blood, plasma, and serum
We’re currently in BETA - Interested in joining? Let us know and we’ll get you set up with early access.