ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

FDA 510(k)

FDA Class 2 ·Microbiology

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

FDA 510(k)

FDA Class 2 ·Microbiology

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

FDA 510(k)

FDA Class 2 ·Microbiology

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

FDA 510(k)

FDA Class 2 ·Microbiology

NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Respiratory Panel 2 plus (RP2plus)

FDA 510(k)

FDA Class 2 ·Pathology

BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

BD PEN NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM)

FDA 510(k)

FDA Class 2 ·Microbiology

BD VACUTAINER PLUS PST II TUBE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml

FDA 510(k)

FDA Class 2 ·Microbiology

PAXGENE BLOOD RNA SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO PAXGENE BLOOD RNA SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

BD PEN NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002;

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TIGECYCLINE (0.25-16 UG/ML)

FDA 510(k)

FDA Class 2 ·Microbiology

VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258

FDA 510(k)

FDA Class 2 ·Clinical Chemistry