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

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

K-ASSAY HS-CRP CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN

FDA 510(k)

FDA Class 2 ·Immunology

CIC-C1Q EIA

FDA 510(k)

FDA Class 2 ·Immunology

HUMAN C-REACTIVE PROTEIN KIT (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Immunology

LAS-R HUMAN COMPLEMENT CLQ TEST

FDA 510(k)

FDA Class 2 ·Immunology

ACA(R) C-REACTIVE PROTEIN (CRP) CALIBRATOR

FDA 510(k)

FDA Class 2 ·Immunology