ACCUPROBE COCCIDIOIDES IMMITIS CULTURE CONFIRM.

FDA 510(k)

FDA Class 2 ·Microbiology

Solana Bordetella Complete Assay

FDA 510(k)

FDA Class 2 ·Microbiology

ANEUVYSION

FDA 510(k)

FDA Class 2 ·Immunology

Aptima CMV Quant Assay

FDA 510(k)

FDA Class 2 ·Microbiology

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

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·ATA SOFTWARE CARTRIDGE (SWM 1000 I-KTB.0.U)