ILLUMINA MISEQDX PLATFORM

FDA 510(k)

FDA Class 2 ·Immunology

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

FDA 510(k)

FDA Class 2 ·Immunology

Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit

FDA 510(k)

FDA Class 2 ·Microbiology

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST/COBAS TAQMAN HCV TEST FOR USE WITH THE HIGH PURE SYSTEM, V2.0

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLICOR HCV TEST, V2.0/COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST V2.0

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

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

AmplideX Fragile X Dx & Carrier Screen Kit

FDA 510(k)

FDA Class 2 ·Immunology

AUTOFLUOR V

FDA 510(k)

FDA Class 2 ·Immunology

IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G

FDA 510(k)

FDA Class 2 ·Immunology

ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS

FDA 510(k)

FDA Class 2 ·Immunology

FIDIS DSDNA

FDA 510(k)

FDA Class 2 ·Immunology

NOVA Lite DAPI dsDNA Crithidia luciliae Kit

FDA 510(k)

FDA Class 2 ·Immunology