Anti-nuclear antibodies (ANA) Medical Devices – Page 2

Below is a list of medical devices and their corresponding complexity (CLIA WAIVED, MODERATE, or HIGH) when testing for Anti-nuclear antibodies (ANA). Note that there may be additional pages of medical devices which test for Anti-nuclear antibodies (ANA) to choose from located at the bottom of the list.

---

---

Medical Device – Page 2	COMPLEXITY
elias usa ANA HEp-2 Analyte: Anti-nuclear antibodies (ANA)	HIGH
elias usa ANA Total EIA Kit Analyte: Anti-nuclear antibodies (ANA)	HIGH
elias usa Synelisa ANA Total Analyte: Anti-nuclear antibodies (ANA)	HIGH
elias usa Synelisa ANA-8 Screen Analyte: Anti-nuclear antibodies (ANA)	HIGH
elias usa Varelisa ANA-8 Screen Analyte: Anti-nuclear antibodies (ANA)	HIGH
elias usa Varelisa ANA-Screen (4) Analyte: Anti-nuclear antibodies (ANA)	HIGH
EUROIMMUN ANA IFA BIOCHIP Test System Analyte: Anti-nuclear antibodies (ANA)	HIGH
Euroimmun ANA IFA:Hep-20-10 kit Analyte: Anti-nuclear antibodies (ANA)	HIGH
Euroimmun ANA screen ELISA (gG) Analyte: Anti-nuclear antibodies (ANA)	HIGH
EUROIMMUN EUROPattern Microscope and Software Analyte: Anti-nuclear antibodies (ANA)	HIGH
GenBio ImmunoDOT Autoimmunity Screening Panel Analyte: Anti-nuclear antibodies (ANA)	MODERATE
General Biometrics ImmunoDOT Autoimmunity Screening Panel Analyte: Anti-nuclear antibodies (ANA)	MODERATE
Gold Standard Antinuclear Antibody (ANA) screen ELISA Test Analyte: Anti-nuclear antibodies (ANA)	HIGH
HELIOS� AUTOMATED IFA SYSTEM (instrument & software) Analyte: Anti-nuclear antibodies (ANA)	HIGH
Helix Diagnostics Antinuclear Antibody Screen EIA Analyte: Anti-nuclear antibodies (ANA)	HIGH
Hemagen ANA System (FA) Analyte: Anti-nuclear antibodies (ANA)	HIGH
Image Navigator by Immuno Concepts Microscope and Software Analyte: Anti-nuclear antibodies (ANA)	HIGH
IMI MICRO21 Analyte: Anti-nuclear antibodies (ANA)	HIGH
IMMCO Diagnostics Autoantibody Test System Analyte: Anti-nuclear antibodies (ANA)	HIGH
IMMCO DIAGNOSTICS IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA Analyte: Anti-nuclear antibodies (ANA)	HIGH

---

Additional Pages:

---