Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis)

FDA registration

Diazyme Laboratories, Inc.·3 products·🇺🇸 United States

Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set

FDA 510(k)

FDA Class 2 ·Hematology

AUTION Sticks 10EA Test Strips

FDA registration

ARKRAY FACTORY USA, INC.·11 products·🇺🇸 United States

AUTION Sticks 10EA Test Strips

FDA registration

ARKRAY Factory, Inc.·11 products·🇯🇵 Japan

AUTION Sticks 10EA Test Strips

FDA registration

ARKRAY, INC.·11 products·🇯🇵 Japan

AESCULAP AG

FDA registration

AESCULAP AG·1 product·🇩🇪 Germany

Assay, Glycosylated Hemoglobin

FDA classification

FDA Class 2 ·Assay, Glycosylated Hemoglobin

FilmArray ME Panel for use on FilmArray Torch

FDA registration

BioFire Diagnostics, LLC·1 product·🇺🇸 United States

Synergy Plus

FDA registration

THE PROMETHEUS GROUP·1 product·🇺🇸 United States

DW-1C

FDA registration

DONGWON MEDICAL CO.,LTD.·1 product·🇰🇷 South Korea

FLAT PANEL DETECTOR, MODEL FDR D-EVO

FDA 510(k)

FDA Class 2 ·Radiology

AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Spinal Vertebral Body Replacement Device

FDA classification

FDA Class 2 ·Spinal Vertebral Body Replacement Device

Solid State X-Ray Imager (Flat Panel/Digital Imager)

FDA classification

FDA Class 2 ·Solid State X-Ray Imager (Flat Panel/Digital Imager)