System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST

GEN. DIAG. CHROMOSTRATE REF. PLASMA

FDA 510(k)

FDA Class 2 ·Hematology

ONLINE TDM Vancomycin Gen.3

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

TINA-QUANT FERRITIN GEN. 4

FDA 510(k)

FDA Class 2 ·Immunology

GEN-X 800/6/50

FDA 510(k)

FDA Class 2 ·Radiology

BEL-GEN Cold Storage Solution

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PERF-GEN Pulsatile Perfusion Solution

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

TINA-QUANT IGG GEN.2

FDA 510(k)

FDA Class 2 ·Immunology

TINA-QUANT ALBUMIN GEN.2

FDA 510(k)

FDA Class 2 ·Immunology

PERF-GEN PULSATILE PERFUSION SOLUTION

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Elecsys Troponin T Gen 5

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GEN-X 800-400 -- MODIFICATION

FDA 510(k)

FDA Class 2 ·Radiology

NEXT GEN EMG ENDOTRACHEAL TUBE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

TINA-QUANT ALBUMIN GEN 2

FDA 510(k)

FDA Class 2 ·Immunology

BEL-GEN COLD STORAGE SOLUTION

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TINA-QUANT HBA1C GEN.2

FDA 510(k)

FDA Class 2 ·Hematology

DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO

FDA 510(k)

FDA Class 2 ·Immunology

BLOOD PRESSURE MONITOR (SPHYGMOMANOMETER), MODEL HT-110

FDA 510(k)

FDA Class 2 ·Cardiovascular

MONOCHROME PERFECTLY FLAT PANEL DISPLAYS, ME SERIES

FDA 510(k)

FDA Class 2 ·Radiology