ENZYME II CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CONTROL PLASMA N

FDA 510(k)

FDA Class 2 ·Hematology

DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISA HBA1C, MODEL K3105A

FDA 510(k)

FDA Class 2 ·Hematology

EMIT 2000 VANCOMYCIN ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Atellica® CH Diazo Total Bilirubin (D_TBil)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M

FDA 510(k)

FDA Class 2 ·Immunology

Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CONTROL PLASMA P

FDA 510(k)

FDA Class 2 ·Hematology

INNOVANCE D-DIMER, MODEL OPBP09

FDA 510(k)

FDA Class 2 ·Hematology

Dimension EXL High-Sensitivity Troponin I (TNIH) Assay

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PROTEIN S AC

FDA 510(k)

FDA Class 2 ·Hematology

EMIT 2000 VANCOMYCIN CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LOCI 8 CALIBRATOR, MODEL KC 646

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STRATUS CS ACUTE CARE D-DIMER

FDA 510(k)

FDA Class 2 ·Hematology

S2 Pigment Removal System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Globe® Pulsed Field System

FDA 510(k)

FDA Class 2 ·Cardiovascular

OT EQUATOR

FDA 510(k)

FDA Class 2 ·Dental