DENSICOMP 250

FDA 510(k)

FDA Class 2 ·Radiology

MRP-5000 HS/MR QUADRATURE BODY COIL(P/N MR-QBC-31)

FDA 510(k)

FDA Class 2 ·Radiology

QBC STAR

Basic UDI-DI

EU IVDD · Eu Ivd General ·Drucker Diagnostics·1 device

QBC AccuTube

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Drucker Diagnostics·1 device

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur HBsAgII/Confirmatory Readypack Reagents and QC Material

Wondfo Cocaine Urine Test (COC 150)

FDA registration

GUANGZHOU WONDFO BIOTECH CO., LTD.·3 products·🇨🇳 China

CLUNGENE Drug Tests Cup

FDA registration

HANGZHOU CLONGENE BIOTECH CO., LTD.·3 products·🇨🇳 China

BTNX Inc. Rapid Response Drugs of Abuse Test (Urine)

FDA registration

BTNX Inc.·3 products·🇨🇦 Canada

Easy@Home Multi-Drug Screen Test, EDOAP-124

FDA registration

ASSURE TECH. (HANGZHOU) CO., LTD.·3 products·🇨🇳 China

Wondfo

FDA registration

WONDFO USA CO., LTD.·3 products·🇺🇸 United States

Wondfo Cocaine Urine Test (COC 150)

FDA registration

GUANGZHOU WONDFO BIOTECH CO., LTD.·3 products·🇨🇳 China

Rapid Diagnostic Tests

FDA registration

ASSURE TECH LLC·3 products·🇺🇸 United States

Easy@Home Multi-Drug Screen Test (EDOAP-124)

FDA registration

EASY HEALTHCARE CORPORATION·3 products·🇺🇸 United States

KAY-PLUS & VARIOUS VANIA SANITARY LINERS & PADS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

QBC STAR, Refurbished

Basic UDI-DI

EU IVDD · Eu Ivd General ·Drucker Diagnostics·1 device

QBC Capillary Centrifuge

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Drucker Diagnostics·2 devices

QBC STAR Tube

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Drucker Diagnostics·2 devices

BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App

FDA 510(k)

FDA Class 2 ·Microbiology

QBC Capillary Blood Tube

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Drucker Diagnostics·2 devices

QBC Venous Blood Tube

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Drucker Diagnostics·2 devices