Devices

PHADIA VarelisA Cardiolipin IgM Antibodies Assay

Model / Serial
Article Number 15696 Lot number #0067
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
USA Nationwide.
Product Description
PHADIA Varelisa Cardiolipin IgM || Cardiolipin autoantibody immunological test system (IgM class antibodies)
Manufacturer
Phadia US Inc
1 Event
- Recall of PHADIA VarelisA Cardiolipin IgM Antibodies Assay

Manufacturer

Phadia US Inc

Manufacturer Address
Phadia US Inc, 4169 Commercial Ave, Portage MI 49002-9701
Manufacturer Parent Company (2017)
Fsii Sweden Holdings I Ab
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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