illumigene Mycoplasma DNA Amplification Assay

FDA 510(k)

FDA Class 2 ·Microbiology

illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10

FDA 510(k)

FDA Class 2 ·Microbiology

HEMOSIL F11 & FV DNA CONTROL

FDA 510(k)

FDA Class 2 ·Microbiology

ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT

FDA 510(k)

FDA Class 2 ·Microbiology

Great Basin Bordetella Direct Test

FDA 510(k)

FDA Class 2 ·Microbiology

ACCUPROBE HISTOPLASMA CAPSULATUM CULTURE CONF.TEST

FDA 510(k)

FDA Class 2 ·Microbiology

Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack

FDA 510(k)

FDA Class 2 ·Microbiology

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

VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

FDA 510(k)

FDA Class 2 ·Immunology

RHIGENE MESACUP-2 TEST RNP, MODEL M7741

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