ENZYME IMMUNOASSAY ANA SCREENING TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

IMMUNOPEROXIDASE TEST SYS. FOR ANA SETER

FDA 510(k)

FDA Class 2 ·Immunology

NOVA 5 NA/K/C1 ALALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EL-ANA PROFILES: EL-ENA/5

FDA 510(k)

FDA Class 2 ·Immunology

EL-ANA PROFILES: EL-ENA/4

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-NUCLEAR ANTIBODY TEST KIT (ANA)

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT

FDA 510(k)

FDA Class 2 ·Immunology

EUROIMMUN ANA IFA: HEP-20-10

FDA 510(k)

FDA Class 2 ·Immunology

ACCESS R-CLONE ANA PROFILE ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

VARELISA RECOMBI ANA PROFILE, MODEL 18496

FDA 510(k)

FDA Class 2 ·Immunology

ANTINUCLEAR ANTIBODY (ANA) SCREENING TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT

FDA 510(k)

FDA Class 2 ·Immunology

KALLESTAD FLORESCENT ANA/AMA/ASMA TEST

FDA 510(k)

FDA Class 2 ·Immunology

K/K (ASMA/ANA) UNIVERSAL BIOPAK

FDA 510(k)

FDA Class 2 ·Immunology

THERATEST EL-ANA PROFILES TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

CDG GAIT ANALYSES SYSTEM

FDA 510(k)

FDA Class 1 ·Physical Medicine

FPL

FDA 510(k)

FDA Class 1 ·Physical Medicine

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·BRACANALYSIS CDX DEVICE

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·PATH VYSION HER-2 DNA PROBE KIT

Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

FDA Pre-Market Approval

FDA Class 3 ·URO VYSION BLADDER CANCER KIT