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ELISA Sm Test System

ZEUS SCIENTIFIC, INC. · Model 2Z2831G · UDI-DI 00845533001076

Prescription
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510(k) clearances
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Adverse events
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Recalls
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Facilities

Description

The ZEUS ELISA Sm Test System is a semi-quantitative immunoassay for the detection of IgG antibodies to Sm in human sera. When performed according to these instructions, the results of this assay may aid in the diagnosis and treatment of autoimmune connective tissue disorders. This device is for In Vitro diagnostic use.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.