COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE

FDA 510(k)

FDA Class 2 ·Microbiology

TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS

FDA 510(k)

FDA Class 2 ·Microbiology

VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (RVNATSP)

FDA 510(k)

FDA Class 2 ·Microbiology

Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit

FDA 510(k)

FDA Class 2 ·Microbiology

BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

LYRA ADENOVIRUS ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFICATION TO PROFLU+ ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

ADENOVIRUS R-GENE US

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFIED DDI SEROCARD CMV IGG TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology

VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

IMX CMV IGG ANTIBODY ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

CMV RQ BIO-ENZABEAD KIT

FDA 510(k)

FDA Class 2 ·Microbiology

IMMULITE CMV IGG

FDA 510(k)

FDA Class 2 ·Microbiology

CYTOMEGALOVIRUS (CMV) ELISA

FDA 510(k)

FDA Class 2 ·Microbiology

CMV ELISA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

CORDIA CMV

FDA 510(k)

FDA Class 2 ·Microbiology

ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

DETECTADOT TM SYSTEM 2000 CMV IGM TEST

FDA 510(k)

FDA Class 2 ·Microbiology

QUANTA LITE CMV IGG ELISA

FDA 510(k)

FDA Class 2 ·Microbiology