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ANA Screen

ZEUS SCIENTIFIC, INC. · Model SM2Z29001G · UDI-DI 00845533002974

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Description

The ANA Screen is a qualitative screening assay designed to detect anti-nuclear antibodies (ANA) in human sera. When performed according to these instructions, this test system is capable of detecting all ANAs commonly tested for, such as those against double stranded DNA (dsDNA), Jo-1, Sm, Sm/RNP, SSA, SSB, and Scl-70. The test is also capable of detecting ANA demonstrating centromere, nucleolar, peripheral, and spindle indirect immunofluorescence antibody (IFA) patterns. This test 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.