MONO-CUBE(TM)

FDA 510(k)

FDA Class 2 ·Immunology

DISPENS-O-DISC BROTH ELUTION DISKS METRON. 80 MCG

FDA 510(k)

FDA Class 2 ·Microbiology

RUBELLA-CUBE(TM)

FDA 510(k)

FDA Class 2 ·Microbiology

Antigen, Inflammatory Response Marker, Sepsis

FDA classification

FDA Class 2 ·Antigen, Inflammatory Response Marker, Sepsis

Sealant, Pit And Fissure, And Conditioner

FDA classification

FDA Class 2 ·Sealant, Pit And Fissure, And Conditioner

MATRIX 101 NEGATIVE GALVANIC GENERATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MAURICE WORLDWIDE SHUNT SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

SYSMEX SE/RAM-1

FDA 510(k)

FDA Class 2 ·Hematology

SYSMEX CA-1000/SYSMEX CA-5000

FDA 510(k)

FDA Class 2 ·Hematology

Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet

FDA classification

FDA Class 2 ·Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet

Warmer, Infant Radiant

FDA classification

FDA Class 2 ·Warmer, Infant Radiant

Access PCT

FDA 510(k)

FDA Class 2 ·Microbiology

Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set

FDA 510(k)

FDA Class 2 ·Microbiology

DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls

FDA 510(k)

FDA Class 2 ·Microbiology

Access PCT, Access PCT Calibrators

FDA 510(k)

FDA Class 2 ·Microbiology

Cabinet, Emission Computed Tomography System

FDA classification

FDA Class 2 ·Cabinet, Emission Computed Tomography System

Alzheimer’S Disease Pathology Assessment Test

FDA classification

FDA Class 2 ·Alzheimer’S Disease Pathology Assessment Test

Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment

FDA classification

FDA Class 2 ·Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment

S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ELECSYS FOLATE II CALSET II

FDA 510(k)

FDA Class 2 ·Clinical Chemistry