TRIGGERPOINT

FDA registration

ART PAC (DONGGUAN) CO LTD·1 product·🇨🇳 China

Leica RUV800 WD175

FDA registration

LEICA INSTRUMENTS (SINGAPORE) PTE LTD.·1 product·🇸🇬 Singapore

GLOW800

FDA registration

LEICA MICROSYSTEMS (SCHWEIZ) AG·1 product·🇨🇭 Switzerland

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ISOLINE 2CR AND ISOLINE 2CT LEADS

UNION PIONEER PUBLIC CO., LTD

FDA registration

UNION PIONEER PUBLIC CO., LTD·1 product·🇹🇭 Thailand

Exercise Band

FDA registration

UNION PIONEER PUBLIC CO., LTD·1 product·🇹🇭 Thailand

UNION PIONEER PUBLIC CO., LTD

FDA registration

UNION PIONEER PUBLIC CO., LTD·1 product·🇹🇭 Thailand

INFINITI® Factor V Leiden Intellipac® Reagent Module

FDA UDI

AUTOGENOMICS, INC·00850009370082·Genotyping system for the detection of the Fa...

INFINITI® Factor II BioFilmChip® Microarray Magazine

FDA UDI

AUTOGENOMICS, INC·00850009370044·Genotyping system for the detection of Factor I...

INFINITI® Factor II Intellipac® Reagent Module

FDA UDI

AUTOGENOMICS, INC·00850009370051·Genotyping system for the detection of Factor ...

INFINITI® Factor II Amplification Mix

FDA UDI

AUTOGENOMICS, INC·00850009370068·Genotyping system for the detection of Factor I...

INFINITI® Factor V Leiden Amplification Mix

FDA UDI

AUTOGENOMICS, INC·00850009370099·Genotyping systme for the detection of the Fact...

INFINITI® Factor V Leiden BioFilmChip® Microarray Magazine

FDA UDI

AUTOGENOMICS, INC·00850009370075·Genotyping system for the detection of the Fac...

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·BREAST COMPANION SOFTWARE SYSTEM

ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20

FDA registration

DOLPHIN LIFE SCIENCE (INDIA) LLP·1 product·🇮🇳 India

BCR-ABL p190 digital PCR detection kit

Device

EU IVDD · Eu Ivd General ·TargetingOne Technology (Beijing) Corporation·On the market

BCR-ABL p210 digital PCR detection kit

Device

EU IVDD · Eu Ivd General ·TargetingOne Technology (Beijing) Corporation·On the market

BCR/ABL (ABL1) Translocation, Dual Fusion Probe

Device

EU IVDR · Eu Ivd Class C ·Cytocell Limited·On the market·32 countries

BCR/ABL (ABL1) Translocation, Dual Fusion Probe

Device

EU IVDR · Eu Ivd Class C ·Cytocell Limited·On the market·32 countries

Alere Afinion HbA1c and ACR on Afinion 2 analyzer

FDA 510(k)

FDA Class 2 ·Hematology