Devices

IsantiSm test kit

Model / Serial
Catalog # 720-240, Lot # T0401, Expiration Date: November 18. 2012
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA Nationwide including the states: CA, ID, NJ, NY, OH, PA, PR, RI, TN, and TX, FL, and the countries of Italy, Chile and Ecuador
Product Description
The Is-anti-Sm test kits****Catalog No: 720-240*** || Product Usage: || The Diamedix Is-anti-Sm Test Kit is an EIA procedure intended for the detection and semi-quantitation of antibodies against the Sm antigen in serum as an aid in the diagnosis of autoimmune disease. The results are reported in ELISA units (EU) per ml determined by comparison to a Calibrator.
Manufacturer
Diamedix Corporation
1 Event
- Recall of IsantiSm test kit

Manufacturer

Diamedix Corporation

Manufacturer Address
Diamedix Corporation, 2140 N. Miami Avenue, Miami FL 33127
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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