Elia Dsdna Immunoassay, Model 14-5500-01, Elia Ana Control, Model 83-1004-01

• • Terminated Z-1107-2021 FDA Class II ·initiated 14 Dec 2020

  Decreased values for EliA ANA Positive Control when using the EliA dsDNA Well lot BFA37/0142 may potentially cause false positive results (increase in patient test results).

510(k) Number

K072393 ↗

FDA Product Code

LSW

Models / Variants

14-5500-01

Elia Ana Control

Model 83-1004-01

Device Class

Class II

Regulation

21 CFR Part 866.5100

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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