Ion PGM Dx System

FDA 510(k)

FDA Class 2 ·Immunology

ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit

FDA 510(k)

FDA Class 2 ·Microbiology

Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack

FDA 510(k)

FDA Class 2 ·Microbiology

ANEUVYSION MULITICOLOR DNA PROBE KIT

FDA 510(k)

FDA Class 2 ·Immunology

ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA

FDA 510(k)

FDA Class 2 ·Microbiology

illumigene Pertussis DNA Amplification Assay

FDA 510(k)

FDA Class 2 ·Microbiology

GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL

FDA 510(k)

FDA Class 2 ·Microbiology

ILLUMINA MISEQDX PLATFORM

FDA 510(k)

FDA Class 2 ·Immunology

STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER

FDA 510(k)

FDA Class 2 ·Hematology

Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System

FDA 510(k)

FDA Class 2 ·Immunology

EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern

FDA 510(k)

FDA Class 2 ·Immunology

ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01

FDA 510(k)

FDA Class 2 ·Immunology

AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10

FDA 510(k)

FDA Class 2 ·Immunology

THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-NATIVE DNA ANTIBODY

FDA 510(k)

FDA Class 2 ·Immunology

DISTAT ANTI-DSDNA KIT

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-NDNA ANTIBODY TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

ZEUS IFA(TM) nDNA Test System, ZEUS dIFine

FDA 510(k)

FDA Class 2 ·Immunology

RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L

FDA 510(k)

FDA Class 2 ·Immunology