T2Bacteria Panel

FDA 510(k)

FDA Class 2 ·Microbiology

T2Bacteria® Panel

FDA 510(k)

FDA Class 2 ·Microbiology

Direct Blood Bacterial Nucleic Acid Detection System

FDA classification

FDA Class 2 ·Direct Blood Bacterial Nucleic Acid Detection System

ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABX ERYTROL

FDA 510(k)

FDA Class 2 ·Hematology

ULTRA-CBX

FDA 510(k)

FDA Class 2 ·Cardiovascular

ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE

FDA 510(k)

FDA Class 2 ·Orthopedic

ABX MICROS CRP

FDA 510(k)

FDA Class 2 ·Hematology

BBX-PET Scanner

FDA 510(k)

FDA Class 2 ·Radiology

ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Curing Light, Model: MaxCure 9

FDA 510(k)

FDA Class 2 ·Dental

Ultrasonic Scaler Tips

FDA 510(k)

FDA Class 2 ·Dental

ABX MICROS ES 60 OT and ABX MICROS ES 60 CT

FDA 510(k)

FDA Class 2 ·Hematology

ABX PENTRA 400: LIPOPROTEINS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABX PENTRA 400 : CRP

FDA 510(k)

FDA Class 2 ·Immunology

ABX PENTRA URINE CAL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry