Devices

Monolisa AntiHBs EIA and Monolisa AntiHBs Calibrator Kit

Model / Serial
Lot #'s: 288BEE and 056CEE
Product Classification
Immunology and Microbiology Devices
Device Class
3
Implanted device?
No
Distribution
Worldwide Distribution -- USA and Canada.
Product Description
Bio-Rad's Monolisa (TM) Anti-HBs EIA test kit, Labeled as, "MONOLISA TM Anti-HBs EIA 25220; || MONOLISA TM Anti-HBs Calibrator Kit 25219... Bio-Rad Laboratories Redmond, WA 98052" || For the qualitative detection of antibody to Hepatitis B Surface Antigen (anti-HBs) in Human Serum and EDTA or citrated plasma.
Manufacturer
Bio-Rad Laboratories
1 Event
- Recall of Monolisa AntiHBs EIA and Monolisa AntiHBs Calibrator Kit

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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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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