Her-2, ER, PR IHControls

FDA 510(k)

FDA Class 2 ·Hematology

BAYER ADVIA CENTAUR HER-2/NEU ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

CHR-631 Rapid Test Reader

FDA registration

KAIWOOD TECHNOLOGY CO., LTD.·1 product·🇹🇼 Taiwan

TBR Zirconnect

FDA registration

SUDIMPLANT SA·2 products·🇫🇷 France

Portable Ovulation Device

FDA registration

KAIWOOD TECHNOLOGY CO., LTD.·1 product·🇹🇼 Taiwan

Luminometer

FDA registration

KAIWOOD TECHNOLOGY CO., LTD.·1 product·🇹🇼 Taiwan

Katalyst Training System

FDA registration

Leader Garment Co., Ltd.·1 product·🇻🇳 Vietnam

NORTE SIRIUS ENTERPRISE CO., LTD.

FDA registration

NORTE SIRIUS ENTERPRISE CO., LTD.·1 product·🇹🇼 Taiwan

TBR IDE@ CONIC

FDA registration

SUDIMPLANT SA·1 product·🇫🇷 France

NORTE SIRIUS ENTERPRISE CO., LTD.

FDA registration

NORTE SIRIUS ENTERPRISE CO., LTD.·1 product·🇹🇼 Taiwan

TipTraQ (TTQ001)

FDA registration

PRANAQ PTE. LTD.·1 product·🇸🇬 Singapore

SNAZZY2

FDA 510(k)

FDA Class 2 ·Physical Medicine

VENTANA HER2 Dual ISH DNA Probe Cocktail

FDA UDI

Ventana Medical Systems, Inc.·07613336158432·

POWDER FREE LATEX EXAMINATION GLOVES

FDA 510(k)

FDA Class 1 ·General Hospital

POWDERED LATEX EXAMINATION GLOVES

FDA 510(k)

FDA Class 1 ·General Hospital

AutoLumo HER-2/neu CLIA Microparticles

Device

EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·PATH VYSION HER-2 DNA PROBE KIT

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·VYSIS ALK BREAK APART FISH PROBE KIT

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·INSITE HER-2/NEU KIT

KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology