Devices

Device Recall MONOLISA ANTIHBs EIA

Model / Serial
All lots distributed from May 5, 2007
Product Classification
Immunology and Microbiology Devices
Device Class
3
Implanted device?
No
Distribution
Worldwide distribution: USA (nationwide) and countries of: Canada, South Africa, and Zimbabwe.
Product Description
The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. || The Bio-Rad MONOLISA Anti-HBs EIA is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection.
Manufacturer
Bio-Rad Laboratories
1 Event
- Recall of Device Recall MONOLISA ANTIHBs EIA

Manufacturer

Bio-Rad Laboratories

Manufacturer Address
Bio-Rad Laboratories, 6565 185th Ave NE, Redmond WA 98052-5039
Manufacturer Parent Company (2017)
Bio-Rad Laboratories Inc
Source
USFDA

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