DBT-P3-001

FDA registration

GENOSS Co., Ltd.·1 product·🇰🇷 South Korea

Lunit INSIGHT DBT

FDA registration

LUNIT INC.·1 product·🇰🇷 South Korea

Lunit INSIGHT DBT v1.1

FDA registration

LUNIT INC.·1 product·🇰🇷 South Korea

SBT-110 (Whole Body Trainer)

FDA registration

MAN & TEL COMPANY LIMITED·1 product·🇰🇷 South Korea

HEMOSIL FACTOR XIII ANTIGEN

FDA registration

INSTRUMENTATION LABORATORY CO.·1 product·🇺🇸 United States

HemosIL Factor XIII

FDA registration

BIOKIT S.A.·1 product·🇪🇸 Spain

K-ASSAY FACTOR XIII CALIBRATOR

FDA registration

DIAGNOSTICA STAGO, INC.·1 product·🇺🇸 United States

HEMOSIL FACTOR XIII ANTIGEN

FDA registration

Instrumentation Laboratory Co.·1 product·🇺🇸 United States

K-ASSAY (R) Factor XIII Reagent, Calibrator, Control

FDA registration

KAMIYA BIOMEDICAL COMPANY LLC·1 product·🇺🇸 United States

HEMOSIL FACTOR XIII ANTIGEN

FDA registration

INSTRUMENTATION LABORATORY CO. - Devens·1 product·🇺🇸 United States

NASKA CO., LTD.

FDA registration

NASKA CO., LTD.·1 product·🇯🇵 Japan

Harmonia DBT

Device

EU MDR · Eu Md Class 2b ·MEDICAL TECHNOLOGIES Ltd·On the market·1 country

Lunit INSIGHT DBT

FDA UDI

Lunit Inc.·08800076000148·

Lunit INSIGHT DBT

Device

EU MDR · Eu Md Class 2a ·Lunit Inc.·On the market·27 countries

Lunit INSIGHT DBT

Device

EU MDR · Eu Md Class 2a ·Lunit Inc.·On the market·20 countries

Lunit INSIGHT DBT

FDA 510(k)

FDA Class 2 ·Radiology

K-ASSAY® Factor XIII Reagent

FDA UDI

KAMIYA BIOMEDICAL COMPANY, LLC·00816426020535·For the quantitative determination of human coa...

K-ASSAY® Factor XIII Control

FDA UDI

KAMIYA BIOMEDICAL COMPANY, LLC·00816426021129·For use as a consistent test sample of known co...

K-ASSAY® Factor XIII Calibrator

FDA UDI

KAMIYA BIOMEDICAL COMPANY, LLC·00816426020764·For the calibration of the K-ASSAY® Factor XIII...

HemosIL Factor XIII Antigen

FDA UDI

INSTRUMENTATION LABORATORY COMPANY·08426950358725·HemosIL Factor XIII Antigen