Devices

Device Recall Abbott RealTime HBV Assay

Model / Serial
All in date lots
Product Classification
Immunology and Microbiology Devices
Device Class
3
Implanted device?
No
Distribution
Nationwide Distribution
Product Description
Abbott RealTime HBV Assay, List 2N40, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA || The Abbott RealTime HBV is an in vitro polymerase chain reaction (PCR) assay for the quantitation of Hepatitis B Virus (HBV) DNA in human plasma or serum from HBV-infected individuals. The Abbott RealTime HBV assay is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis and for use as an aid in assessing viral response to antiviral treatment as measured by changes in plasma or serum HBV DNA levels. This assay is not intended for use as a screening test for HBV or as a diagnostic test to confirm the presence of HBV infection.
Manufacturer
Abbott Molecular
1 Event
- Recall of Device Recall Abbott RealTime HBV Assay

Manufacturer

Abbott Molecular

Manufacturer Address
Abbott Molecular, 1300 E Touhy Ave, Des Plaines IL 60018-3315
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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