hCG absent controls are sourced from male plasma donors. hCG present controls are prepared by spiking hCG standard into pooled plasma from male donors. All plasma samples have been heat-inactivated, defibrinated, and clarified. A low concentration of ProClin preservative has been added to the resultant plasma controls to extend their shelf life by effectively inhibiting a broad spectrum of microbes. Both controls are plasma samples. a typical patient sample uised for hCG test performance
hCG absent controls are sourced from male plasma donors. hCG present controls are prepared by spiking hCG standard into pooled plasma from male donors. All plasma samples have been heat-inactivated, defibrinated, and clarified. A low concentration of ProClin preservative has been added to the resultant plasma controls to extend their shelf life by effectively inhibiting a broad spectrum of microbes. Both controls are plasma samples. a typical patient sample uised for hCG test performance
Shipping & Handling
Shipped In
Cold Packs
Safety & Storage
Storage Temperature
Store at 2-8°C (35.6-46.4°F)
Safety Statement
For in vitro diagnostic use only. For Prescription Use Only. Read the product insert completely before using the ADEXUSDx® hCG Control Set. The ADEXUSDx® hCG Control Set is an unassayed quality control (QC) set designed for monitoring the reliability of tests for detection of human chorionc gonadotropin. This product was manufactured in NOWDiagnostics, Inc. facilities based on a quality system compliant with GMP for Medical Devices and ISO 13485
For in vitro diagnostic use only. For Prescription Use Only. Read the product insert completely before using the ADEXUSDx® hCG Control Set. The ADEXUSDx® hCG Control Set is an unassayed quality control (QC) set designed for monitoring the reliability of tests for detection of human chorionc gonadotropin. This product was manufactured in NOWDiagnostics, Inc. facilities based on a quality system compliant with GMP for Medical Devices and ISO 13485
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.
TIME TO RESULT
10 Minutes
CLASS
Assay Controls
COUNTRY OF ORIGIN
United States
RESULT WINDOW
10-30 Minutes
SAMPLE TYPE
Human venous whole blood, fingerstick whole blood, plasma, and serum
PRECAUTIONARY STATEMENTS
Plasma sourced from human plasma donors who tested negative for HIV,Hepatitis C. All control samples have been heat-inactivated, defibrinated, and clarified. Heat activation of samples was performed for 30 minutes at 65⁰C. DO NOT USE the controls if the droppers were not capped. DO NOT USE after the expiration date or 30 days after opening whichever comes first. Expiration date for unopened controls is indicated on the label. After opening controls are good for 30 days. Refer to CDC guidelines and local regulations for handling and disposal of positive and negative controls.
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Shipping & Handling
Shipped In
Cold Packs
Safety & Storage
Storage Temperature
Store at 2-8°C (35.6-46.4°F)
Safety Statement
For in vitro diagnostic use only. For Prescription Use Only. Read the product insert completely before using the ADEXUSDx® hCG Control Set. The ADEXUSDx® hCG Control Set is an unassayed quality control (QC) set designed for monitoring the reliability of tests for detection of human chorionc gonadotropin. This product was manufactured in NOWDiagnostics, Inc. facilities based on a quality system compliant with GMP for Medical Devices and ISO 13485
Regulatory & Compliance
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